St. Jude clinical trials emphasize the innovative and collaborative research between our doctors and scientists, who work together to find cures for children.
Children who are referred for a clinical trial at St. Jude will receive leading therapies, including standard and investigational treatments, in a compassionate, supportive setting that meets the highest standards of care. We provide phase 1, phase 2 and phase 3 clinical trials in childhood cancer, hematology, infectious diseases, supportive care and healthy volunteer studies.
We invite referring clinicians to subscribe to our monthly Clinical Trials Alert email. This newsletter will notify you of important research protocols at St. Jude, as well as new initiatives, research news and information at the hospital.
Referral contact information
Contact the Physician/Patient Referral Office to refer a child to St. Jude.
Call:
1-888-226-4343 (toll-free)
Fax:
901-595-4011
Email:
referralinfo@stjude.org
Online:
Referral Contact Form
24-hour pager:
1-800-349-4334
For Families
Taking part in clinical research is a decision that should be discussed with family members and your child's doctor. We hope you will find the information in this section helpful in making the best choices for your child.
Browse Clinical Trials
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Featured Trial
LVXSCID-ND: Gene Transfer for X-Linked Severe Combined Immunodeficiency (SCID) in Newly Diagnosed Infants
Diseases Treated:
X-linked Severe Combined Immunodeficiency (SCID-X1)
Eligibility:
- Diagnosis of Severe Combined Immunodeficiency Disease, X-linked (SCID-X1)
- Newborn to 2 years of age
- No prior therapy with allogeneic stem cell transplantation
- No HIV infection
CPPGAL: Characterization of the Patient Population with Galactosialidosis
Diseases Treated:
Galactosialidosis
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
ED0157: Phase 1 Pediatric PK/PD Study
A Phase I, Open-Label, Single-Dose, Non-Randomized Study to Evaluate Pharmacokinetics and Pharmacodynamics of Edoxaban in Pediatric Patients
Diseases Treated:
For patients at risk for blood clots
Eligibility:
- Participant has a diagnosis requiring anticoagulant therapy.
- Participant has completed their standard anticoagulant therapy.
- Participant is not receiving active therapy for a malignant condition.
- Participant is less than 18 years of age at the time of consent.
- Participant and legal guardian agree to food and drug restrictions during study.
EDO312: Edoxaban, a new Oral Anticoagulant, for Blood Clots in Children
Phase III Trial to Evaluate the Pharmacokinetics and Pharmacodynamics of Edoxaban and to Compare the Efficacy and Safety of Edoxaban with Standard Anticoagulant Therapy in Children with Venous Thromboembolism (VTE)
Diseases Treated:
Blood clots (venous thromboembolism)
Eligibility:
This clinical trial is open only to St. Jude patients.
- Newborn to 17 years old (must be younger than 18)
- Diagnosis of blood clot in a vein (venous thromboembolism, also called VTE)
- Requires anticoagulant therapy for at least 90 days
- Received at least 5 days of heparin therapy prior to study
INSIGHT-HD: Investigating the Genetics of Hematologic Diseases
Diseases Treated:
Non-malignant blood diseases (non-therapeutic)
Eligibility:
- Receiving therapy or a consultation for a non-malignant blood disorder
- Biological relatives (with or without a non-malignant blood disorder) who agree to undergo genetic testing
LVXSCID-ND: Gene Transfer for X-Linked Severe Combined Immunodeficiency (SCID) in Newly Diagnosed Infants
A Pilot Feasibility Study of Gene Transfer For X-Linked Severe Combined Immunodeficiency (SCID) in Newly Diagnosed Infants Using a Self-Inactivating Lentiviral Vector To Transduce Autologous CD34 + Hematopoietic Cells
Diseases Treated:
X-linked Severe Combined Immunodeficiency (SCID-X1)
Eligibility:
- Diagnosis of Severe Combined Immunodeficiency Disease, X-linked (SCID-X1)
- Newborn to 2 years of age
- No prior therapy with allogeneic stem cell transplantation
- No HIV infection
PKiDS: Pyruvate Kinase Deficiency (PKD) Natural History Study
Diseases Treated:
Pyruvate kinase deficiency (PKD)
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
- Participants of all ages with biochemically or genetically diagnosed PKD.
- Participants with a hemolytic anemia and a family member with genetically diagnosed PKD.
- The participant or the guardian of the participant is willing and able to give written informed consent and/or assent.
REHASH: Barriers to Hydroxyurea Adherence for Sickle Cell Disease
Re-Aiming at Hydroxyurea Adherence for Sickle Cell with MHealth
Diseases Treated:
Eligibility:
This study is limited to patients living in the Memphis, Tennessee region.
Phase I
- Diagnosis of sickle cell disease
- Between 15 and 44.9 years old
- Speaks English
Phase II
- Diagnosis of sickle cell disease
- Between 15 and 44.9 years old
- Receiving hydroxyurea treatment for sickle cell disease
- Owns a smart phone
- Not currently receiving text messages for improving hydroxyurea adherence
- Not currently undergoing hydroxyurea dose escalation
- Not on any investigational new drug intervention study for sickle cell disease
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10-CBA: A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adult Patients with Hematologic Malignancies and Other Indications
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
- Participant is receiving an allogeneic hematopoietic stem cell transplant at St. Jude Children’s Research Hospital using an unlicensed cord blood unit (CBU).
- The patient has a disorder affecting the hematopoietic system that is either inherited, acquired, or a result from myeloablative treatment.
BMTFU: Protocol for Collecting Long-Term Follow-Up Data on Recipients of Hematopoietic Stem Cell Transplant
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
DE0605: Defibrotide for Patients With Hepatic Veno-occlusive Disease: A Treatment IND Study
Diseases Treated:
Hepatic veno-occlusive disease
Eligibility:
- The patient must have diagnosis of hepatic VOD
- Patients must also provide voluntary written informed consent to the protocol to be eligible for the study.
GENEFU: Long-Term Follow-Up of Patients who have Received Gene Therapy/Gene Marked Products
Long-Term Follow-Up of Patients who have Received Gene Therapy/Gene Marked Products
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
- Participant received an integrating retroviral or lentiviral vector based gene transfer or gene marked product at St. Jude Children’s Research Hospital within the past 15 year time period.
NCBP01: Safety Study of Unlicensed, Investigational Cord Blood Units Manufactured by the NCBP for Unrelated Transplantation
A Multicenter Safety Study of Unlicensed, Investigational Cryopreserved Cord Blood Units (CBUs) manufactured by the National Cord Blood Program (NCBP) and provided for Unrelated Hematopoietic Stem Cell Transplantation of Pediatric and Adult Patients
Diseases Treated:
Leukemia and other blood diseases
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
- Participant is receiving an allogeneic hematopoietic stem cell (HSC) transplant at St. Jude Children's Research Hospital using an unlicensed cord blood unit (CBU).
- Participant may be of any age and either gender.
- Participant has a medical disorder affecting the hematopoietic system that is inherited, acquired, or a result from myeloablative treatment.
- Participant is receiving HPC-CORD BLOOD product manufactured by NCBP (at least one, if the graft contains more than one units).
NMDPD: Protocol for a Research Database for Hematopoietic Stem Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries
National Marrow Donor Program: A research Database for Allogeneic Unrelated Hematopoietic Stem Cell Transplantation
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
REF2HCT: Haploidentical Bone Marrow Transplant for Leukemia and Lymphoma
Provision of TCRγδ T Cells and Memory T Cells plus Selected Use of Blinatumomab in Naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies Relapsed or Refractory despite Prior Transplantation
Diseases Treated:
Eligibility:
- 21 years old and younger
- Diagnosed with one of the following that has come back or did not improve after bone marrow transplant
- Acute lymphoblastic leukemia (ALL)
- Acute myeloid leukemia
- Myeloid sarcoma
- Chronic myeloid leukemia (CML)
- Juvenile myelomonocytic leukemia (JMML)
- Myelodysplastic syndrome (MDS)
- Non-Hodgkin lymphoma (NHL)
- Has a family member who is a suitable stem cell donor
SJHOME: At-Home Care after Stem Cell Transplant
Health and Outpatient Management Experiences
Diseases Treated:
Non-therapeutic
Eligibility:
This is a non-therapeutic clinical trial open only to St. Jude patients.
- 12 years old or younger
- Has had a hematopoietic stem cell transplant (HCST)
- Recruitment occurs within two weeks before or after discharge from transplant admission
- Prescribed oral medication at discharge
- Speaks and reads English
TWIPES: Bath Wipes in Reducing Skin Bacteria in Younger Patients Undergoing Stem Cell Transplant
A Pilot Study of the Safety Followed by a Randomized Controlled Trial of the Efficacy of Non-Antimicrobial Theraworx™ Bath Wipes in the Reduction of Skin Colonization with Vancomycin-Resistant Enterococci Compared to Standard Bath Wipes in Children Undergoing Hematopoietic Stem Cell Transplantation
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
This clinical trial has inclusion and exclusion criteria. See full trial for specifics.
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ADV1217: WEE1 Inhibitor MK-1775 and Local Radiation Therapy in Treating Younger Patients With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas
Diseases Treated:
Newly diagnosed Diffuse Intrinsic Pontine Glioma (DIPG)
Eligibility:
- Participant is > 36 month and < 21 years of age at the time of study enrollment.
- Participant has newly diagnosed DIPG.
- Participant has a brainstem tumor that was biopsied and proven to be one of the following: anaplastic astrocytoma, glioblastoma, gliosarcoma, or anaplastic mixed glioma.
- Participant has not received any prior chemotherapy, radiation therapy, immunotherapy or bone marrow transplant for the treatment of DIPG. Prior dexamethasone and/or surgery are allowed.
ADV1416: A Study of Ramucirumab in Children with Solid Tumors and Brain Tumors
Diseases Treated:
Eligibility:
- 12 months old or older and younger than 21 years old
- Diagnosis:
- Part A - Non-central nervous system (CNS) tumor that returned after treatment or did not respond to treatment
- Part B – CNS tumor that returned after treatment or did not respond to treatment
- No other proven therapy options
BRF116: A Study to Determine Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib In Children and Adolescent Subjects
Diseases Treated:
Solid tumors, giomas, hystiocytosis
Eligibility:
- Participant is greater or equal to 12 months and less than 18 years at the time of signing the informed consent form.
- Participant has BRAF V600 mutation positive tumor as confirmed in a CLIA-approved laboratory or equivalent
- Participant has recurrent disease, refractory disease, or progressive disease after having received at least one standard therapy for their disease, OR participant has metastatic (or surgically unresectable) melanoma, and is being enrolled for first-line treatment. Melanoma participants with CNS involvement may be enrolled.
CCL0922: Modafinil in Treating Children With Memory and Attention Problems Caused by Cancer Treatment for a Brain Tumor
Diseases Treated:
Brain Tumor : Previously treated brain tumors
Eligibility:
- Age is > 6 years and < 17 years & 10 months at the time of study entry.
- Off treatment and progression–free for at least 12 months and less than and equal to 14 years.
- Diagnosis of a primary brain tumor treated with at least one of the following :
- Neurosurgical resection of the brain tumor;
- Cranial irradiation;
- Any chemotherapy to treat the brain tumor
CNS1123: Chemotherapy Followed by Radiation Therapy in Treating Younger Patients With Newly Diagnosed Localized Central Nervous System Germ Cell Tumors
Diseases Treated:
Newly diagnosed localize primary NGGCT or newly diagnosed localized germinoma
Eligibility:
- Participant is > 3 years and < 21 years at the time of enrollment.
- Participant has newly diagnosed localized primary NGGCT or newly diagnosed localized germinoma (has not spread to other parts of the brain or spine).
- Participant must have adequate bone marrow function.
- Participant must have normal renal and liver function for age.
- NO prior therapy except surgery and/or steroids.
CNS831: Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Younger Patients With Newly Diagnosed Ependymoma
Diseases Treated:
Intracranial ependymoma
Eligibility:
- Patient must be greater than 12 months of age and less than 21 years of age at enrollment
- Patients with newly diagnosed intracranial ependymoma without evidence of metastatic disease (confirmed by MRI brain and spine along with lumbar puncture to check CSF)
- Patients with diagnosis of spinal cord ependymoma, myxopapillary ependymoma, subependymoma, ependymoblastoma, or mixed glioma are not eligible
- No prior treatment other than surgical intervention and corticosteriods
EZH102: Tazemetostat in Children and Young Adults with Synovial Sarcoma or INI1-Negative Tumors
Diseases Treated:
- Rhabdoid tumor
- Synovial sarcoma
- INI 1-negative tumor
Eligibility:
- Between 6 months and 21 years old
- Relapsed or refractory rhabdoid tumors, INI1-negative tumors or synovial sarcoma
LOXO-TRK: Testing Larotrectinib (LOXO-101) in Children with Advanced Solid Tumors or Brain Tumors
Diseases Treated:
Solid Tumors, Central Nervous System Tumors
Eligibility:
Phase 1
- Birth through 21 years of age with locally advanced or metastatic solid tumor or primary CNS tumor that has progressed or was nonresponsive to therapy and for which there is no standard or available curative therapy, OR
- Infants from birth and older with diagnosis of malignancy and with documented NTRK fusion that has progressed or was nonresponsive to therapy and for which there is no standard or available curative therapy, OR
- Patients with locally advanced infantile fibrosarcoma who would require disfiguring surgery or limb amputation to achieve complete surgical resection
Phase 2
- Infants from birth and older at C1D1 with locally advanced or metastatic infantile fibrosarcoma OR
- Birth through 21 years old at C1D1 with locally advanced or metastatic solid tumor or primary CNS tumor that has relapsed, progressed or was not responsive to therapy and for which no standard or available curative therapy with a NTRK gene funsion OR
- More than 21 years old with tumor diagnosis typical of a pediatric patient and an NTRK fusion
MEK116: Study to Investigate Safety, Pharmacokinetic (PK), Pharmacodynamic (PD) and Clinical Activity of Trametinib in Subjects With Cancer or Plexiform Neurofibromas and Trametinib in Combination With Dabrafenib in Subjects With Cancers Harboring V600 Mutations
Diseases Treated:
Relapsed or refractory solid tumor
Eligibility:
- Participant is at least one month old and younger than 18 years old at the time of signing the informed consent (in Part A, participants < 2 years of age are not included).
- Participant has a histologically confirmed solid tumor
- Participant has a disease that is relapsed or refractory to all potentially curative standard treatment regimens, or has a disease for which there is no standard treatment regimen that is potentially curative.
MEMCRT: Memantine to Prevent Thinking Problems in Children Receiving Radiation for Certain Brain Tumors
Diseases Treated:
Eligibility:
- Between 6 and 21 years old
- Diagnosis of localized low-grade glioma, craniopharyngioma, ependymoma or germ cell tumor
- Initiating focal cranial radiation therapy (photon or proton)
- Able to swallow pills
- Participant and parent/legal guardian speak, read and understand English
- Normal ECG and laboratory tests
- Adequate vision and hearing
PBTC29: Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Diseases Treated:
Eligibility:
- Participant is ≥ 3 but ≤ 21 years of age at registration.
- Participant has a diagnosis of low grade glioma (Grades I & II) or optic pathway gliomas with clinical and/or radiographic evidence of progression.
- Participant received last fraction of local irradiation to the primary tumor ≥ 12 weeks prior to registration, or does not apply.
PBTC39: Peginterferon Alfa-2b in Treating Younger Patients With Craniopharyngioma That is Recurrent or Cannot Be Removed By Surgery
Diseases Treated:
Unresectable or recurrent craniopharyngioma
Eligibility:
- Participant has a histologically verified diagnosis of craniopharyngioma.
- Participant has recovered from acute toxicities of all prior therapy before entering this study.
- Participant has not received prior interferon, either systemic or into the tumor cyst.
- Participant does not have evidence of metastatic tumor.
PBTC42: Palbociclib Isethionate in Treating Younger Patients With Recurrent, Progressive, or Refractory Central Nervous System Tumors
Diseases Treated:
Retinoblastoma protein 1 (Rb1) positive recurrent, progressive, or refractory central nervous system tumors
Eligibility:
- Between 4 and 21 years old
- Able to swallow capsules
- Rb1-positive recurrent, progressive or refractory central nervous system (CNS) tumor or DIPG
- Stable neurological deficit for at least 1 week prior to enrollment
- Last dose of known myelosuppressive anticancer chemotherapy at least 3 weeks prior to enrollment
- Last fraction of focal irradiation > 2 weeks prior to enrollment
PBTC45: MK-3475 in Treating Children with Recurrent, Progressive or Refractory HGGs, DIPGs and Hypermutated Brain Tumors
Diseases Treated:
Recurrent, progressive, or refractory high-grade gliomas
Eligibility:
- Participant has recurrent, progressive or refractory non-brainstem high-grade glioma or diffuse intrinsic pontine glioma (DIPG)
- Participant is 1 to 18 years of age
- Participant has bi-measurable disease on MRI
- Participant has received prior radiation therapy and/or chemotherapy and has not received myelosuppressive anticancer chemotherapy for at least three (3) weeks
PBTC47: A Clinical Trial of the Drug, Panobinostat, in Children with Brain Tumors
Diseases Treated:
Diffuse Intrinsic Pontine Glioma (DIPG)
Eligibility:
- Diagnosis of progressive diffuse intrinsic pontine glioma (DIPG) or an increase in the bi-dimensional measurement or the appearance of a new tumor lesion since diagnosis
- At least 2 but not more than 22 years old
- Able to swallow capsules whole
PBTC48: Study of the Optune Device in Children with Certain High-Grade Glioma and Ependymoma Brain Tumors
Diseases Treated:
High-grade glioma (HGG), ependymoma
Eligibility:
- Between 5 and 21 years old
- Diagnosis of supratentorial high-grade glioma (HGG) or supratentorial ependymoma that is recurrent, progressive or refractory
- Head circumference of at least 44 cm
- Failed standard therapy with no other available treatment options
- Recovered from prior chemotherapy, immunotherapy or radiotherapy
- Willing and able to use the device at least 18 hours a day for at least 23 days and keep head shaved throughout treatment
PNOC001: Phase II Study of Everolimus for Recurrent or Progressive Low-Grade Gliomas in Children (CC #120817)
Diseases Treated:
Recurrent or progressive low grade gliomas (brain tumors)
Eligibility:
- Participant is three (3) to twenty-one (21) years of age.
- Patient has refractory, progressive or recurrent confirmed low-grade glioma (WHO grade I or II) that was confirmed histologically at initial diagnosis.
- Participant received his or her last dose of myelosuppressive anticancer chemotherapy at least three (3) weeks prior to study registration, or at least six (6) weeks if nitrosourea.
- Participant received his or her last dose of other investigational or biological agent more than seven (7) days prior to study entry.
PNOC002: A Safety Phase 0, and Pilot Efficacy Study of Vemurafenib, an oral inhibitor of BRAFV600E in Children with Recurrent/Refractory BRAFV600E-Mutant Brain Tumors [PNOC-002, CC #120819, IND#116870 (exempt)]
Diseases Treated:
Brain tumors (recurrent and refractory)
Eligibility:
- 25 years or younger at time of registration
- Histologically confirmed diagnosis of a primary central nervous system tumor
- Positive test for the BRAFV600E or the BRAF Ins T mutation at a CLIA-approved laboratory
RERTEP: Surgery and Second-Course Radiation Therapy in Treating Younger Patients With Recurrent Ependymoma
Diseases Treated:
Recurrent ependymoma
Eligibility:
- Progressive intracranial ependymoma after prior focal irradiation
- At least 1 year old and younger than 21 years old
- Adequate performance status (ECOG less than 3)
- Does not require mechanical ventilation
- Interval from start of initial radiation therapy to enrollment greater than 9 months
RT2CR: Limited Surgery and Proton Beam Radiation Therapy in Treating Younger Patients with Brain Tumors
Diseases Treated:
Eligibility:
- 21 years of age or younger
- Diagnosis of craniopharyngioma
- Has not been previously treated with radiation therapy
RT3CR: Proton Therapy for Pediatric Craniopharyngioma
Diseases Treated:
Eligibility:
- 21 years old or younger
- Diagnosis of craniopharyngioma
SJATRT: Phase II Study of Alisertib Therapy for Rhabdoid Tumors
Diseases Treated:
Brain Tumor : Recurrent, progressive, or newly diagnosed atypical teratoid rhabdoid brain tumors (ATRT)
Solid Tumor : Progressive extra-CNS malignant rhabdoid solid tumors (MRT)Eligibility:
- Has one of these types of tumors:
- Newly diagnosed atypical teratoid rhabdoid tumors (ATRTs) or synchronous extraneural ATRTs
- ATRTs or malignant rhabdoid tumors (MRTs) that have come back after previous treatment (recurrent disease)
- ATRTs or MRTs that are growing after previous treatment (progressive disease)
- 21 years of age or younger
SJDAWN: Molecular-Based Therapy for Aggressive Brain and Spinal Cord Tumors in Children and Young Adults
Diseases Treated:
Brain tumor, medulloblastoma, ependymoma
Eligibility:
Ages for Study Enrollment
- Stratum A (ribociclib and gemcitabine): Between 1 and 24 years old with recurrent, progressive or refractory non-WNT, non-sonic hedgehog (SHH) (NWNS) medulloblastoma or ependymoma
- Stratum B (ribociclib and trametinib): Between 1 and 24 years old with recurrent, progressive, or refractory central nervous system (CNS) tumors, including:
- High-grade glioma
- Atypical teratoid rhabdoid tumor (ATRT)
- SHH and WNT medulloblastoma
- CNS embryonal tumors [previously called PNET])
- Stratum C (ribociclib and sonidegib): Between 10 and 39 years old with recurrent, progressive, or refractory SHH medulloblastoma and copy number loss of 9q or PTCH1 mutation. (This stratum is only open to patients with SHH medulloblastoma who are fully grown. Patients younger than 18 years old will have bone age to determine if fully grown)
Screening Phase Eligibility
Inclusion Criteria:
- Participants with recurrent, progressive, or refractory brain tumors
- At least 1 year old and younger than 25 years old at the time of screening. Exception: Participants with recurrent, progressive or refractory medulloblastoma who are at least 1 year old and younger than 40 years of age at the time of study screening are eligible for screening.
- Participants and/or guardian have the ability to understand and the willingness to sign a written informed consent document according to institutional guidelines.
Exclusion Criteria:
- Recurrent, progressive or refractory low grade glioma (LGG)
- Prior exposure to a CDK4/6 inhibitor
- History of clinically significant, uncontrolled heart disease and/or repolarization abnormalities
- History of QTc prolongation
SJMB12: A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma/PNET
Diseases Treated:
Medulloblastoma (includes all variants of medulloblastoma and posterior fossa PNET)
Eligibility:
- Diagnosis of newly medulloblastoma
- At least 3 years old and younger than 22 years old (Strata W, S or N) OR
- At least 22 years old and younger than 40 years old AND has SHH medulloblastoma (Stratum S)
- Has not received previous treatment with radiation therapy or chemotherapy
- Must start treatment within 36 days of surgery to remove the tumor
SOCFUN: Social Functioning in Survivors of Pediatric Brain Tumors
Diseases Treated:
Brain tumor
Eligibility:
This study is open only to patients at St. Jude Children’s Research Hospital.
- Diagnosis of medulloblastoma or other brain tumor
- Between 8 and 12 years old
- At least 2 years after completion of therapy
- Full-time student
- Speaks English
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HSESID: Database for HLH Immunodeficiency Disease
A Registry for Hemophagocytic Lymphohistiocytosis (HLH)
Eligibility:
- Diagnosis of a primary immunodeficiency predisposed to hemophagocytic lymphohistiocytosis
- Meets at least 4 of 8 diagnostic criteria for HLH as defined by the Histiocyte Society and is receiving HLH-directed therapy
- High suspicion of isolated Central Nervous System-HLH and is receiving HLH-directed therapy
LiSTENING: Learning in Story: Elicited Narrative Informs Navigating Genetics
Eligibility:
This is a non-therapeutic clinical trial open to St. Jude patients only.
Participants have been pre-identified by the primary care team as an English-speaking, four-member family unit diagnosed with TP53 mutation.
PG4KDS: Clinical Implementation of Pharmacogenetics
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients
SJFAMILY: Study of Cancer in Families
Familial Investigations of Childhood Cancer Predisposition
Diseases Treated:
Non-therapeutic clinical trial
Eligibility:
This is a non-therapeutic clinical trial that is open to children and adults with familial cancer and to their eligible family members.
Note: This is a research study and is not meant to be a substitute for clinical genetic testing. Families may never receive results from the study or may receive results many years from the time they enroll. If you are interested in clinical genetic testing, please consider seeing a local genetic counselor or other genetics professional. If you have already had clinical genetic testing and meet eligibility criteria for the SJFAMILY study, as outlined below, you may enroll regardless of the results of your clinical genetic testing.
In this research study, the definition of “Familial Cancer” is met if any of the following is present:
- An individual with a history of cancer diagnosed under 26 years of age who has at least one first, second or third degree relative with a history of cancer diagnosed under 51 years of age; OR
- An individual who has been diagnosed with more than one cancer, at least one of which was diagnosed under 26 years of age; OR
- An individual with a clinical or molecular diagnosis of a known cancer predisposition syndrome
Eligible individuals include:
- An individual who meets the definition of “Familial Cancer,” as above
- Blood relatives of the above individual with familial cancer, who are affected or unaffected by cancer
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BUZZOFF: Antimalarial Drug Effectiveness in Healthy Adults
First-in-Human, Dose-Escalation Study of an Oral Plasmodium Falciparum Plasma Membrane Protein Inhibitor
Diseases Treated:
Malaria
Eligibility:
- Healthy male or female adults
- Age 18 to 55 years old
- Minimum weight of 50 kg with BMI between 18 and 34 kg/m^2
- Females must be post-menopausal or have documented hysterectomy or bilateral oophorectomy
FLUVIT: A Double-Blind Randomized, Placebo Controlled Study of Antibody Induction By Vitamin Supplementation At The Time Of Influenza Virus Vaccination In Children
Eligibility:
- Participant is age two (2) to eight (8) years inclusive at the time of enrollment.
- Participant is not currently using investigational or immunosuppressive drugs (e.g. steroids) at the time of enrollment.
- Participant is not currently taking a daily (routine) Vitamin A, D or multi-vitamin. Note: Participant who report occasional or sporadic vitamin use will be allowed to enroll.
SENDAI: A Phase I Study of Unmodified Live Intranasal Sendai Virus Vaccine in Children and Toddlers: Assessment of Safety and Immunogenicity
Eligibility:
- Child is greater than or equal to twelve (12) months and less than twenty-four (24) months.
- Child has adequate blood, liver and kidney function.
- Child has no history of lung disease, asthma, and hospitalization for respiratory illness, immunodeficiency, sickle cell disease, or any other serious underlying condition.
XPD12-077: Cognitive, Academic and Psychosocial Functioning in Long-Term Survivors of Pediatric Stem Cell Transplantation
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
St. Jude patients:
- Treated with an allogeneic bone marrow or stem cell transplant at St. Jude
- 8 years of age or older
- Younger than 21 at time of transplant
- More than 5 years from date of transplant
Healthy volunteers (comparison group):
- 8 years of age or older
- Primarily speaks English
- No known history of serious illness
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HSESID: Database for HLH Immunodeficiency Disease
A Registry for Hemophagocytic Lymphohistiocytosis (HLH)
Eligibility:
- Diagnosis of a primary immunodeficiency predisposed to hemophagocytic lymphohistiocytosis
- Meets at least 4 of 8 diagnostic criteria for HLH as defined by the Histiocyte Society and is receiving HLH-directed therapy
- High suspicion of isolated Central Nervous System-HLH and is receiving HLH-directed therapy
LCH-CLO: Clofarabine for Langerhans Cell Histiocytosis and LCH-related disorders
Phase II Study of Clofarabine in Patients with Recurrent or Refractory Langerhans Cell Histiocytosis and LCH-Related Disorders
Diseases Treated:
Langerhans cell histiocytosis and LCH-related disorders
Eligibility:
- Prior diagnosis of Langerhans cell histiocytosis or LCH-related disorder
- Evidence of active disease
- Performance Score > 70% (use Lansky score for age < 16 and Karnofsky score for age ≥16)
- Any age
- Adequate organ functions
LCH-IV: Clinical Trial for Children and Adolescents with Langerhans Cell Histiocytosis
International Collaborative Treatment Protocol for Children and Adolescents with Langerhans Cell Histiocytosis
Diseases Treated:
Eligibility:
- Diagnosis of Langerhans cell histiocytosis
- Younger than 18 years old
- Meets inclusion criteria for the respective stratum
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GENEFU: Long-Term Follow-Up of Patients who have Received Gene Therapy/Gene Marked Products
Long-Term Follow-Up of Patients who have Received Gene Therapy/Gene Marked Products
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
- Participant received an integrating retroviral or lentiviral vector based gene transfer or gene marked product at St. Jude Children’s Research Hospital within the past 15 year time period.
HSESID: Database for HLH Immunodeficiency Disease
A Registry for Hemophagocytic Lymphohistiocytosis (HLH)
Eligibility:
- Diagnosis of a primary immunodeficiency predisposed to hemophagocytic lymphohistiocytosis
- Meets at least 4 of 8 diagnostic criteria for HLH as defined by the Histiocyte Society and is receiving HLH-directed therapy
- High suspicion of isolated Central Nervous System-HLH and is receiving HLH-directed therapy
LVXSCID-ND: Gene Transfer for X-Linked Severe Combined Immunodeficiency (SCID) in Newly Diagnosed Infants
A Pilot Feasibility Study of Gene Transfer For X-Linked Severe Combined Immunodeficiency (SCID) in Newly Diagnosed Infants Using a Self-Inactivating Lentiviral Vector To Transduce Autologous CD34 + Hematopoietic Cells
Diseases Treated:
X-linked Severe Combined Immunodeficiency (SCID-X1)
Eligibility:
- Diagnosis of Severe Combined Immunodeficiency Disease, X-linked (SCID-X1)
- Newborn to 2 years of age
- No prior therapy with allogeneic stem cell transplantation
- No HIV infection
-
AT1026: Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
PACTG1026S-Pharmacokinetic Properties of Antiretroviral Drugs During Pregnancy
Diseases Treated:
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
- The subject has been enrolled on IMPAACT P1025.
BUZZOFF: Antimalarial Drug Effectiveness in Healthy Adults
First-in-Human, Dose-Escalation Study of an Oral Plasmodium Falciparum Plasma Membrane Protein Inhibitor
Diseases Treated:
Malaria
Eligibility:
- Healthy male or female adults
- Age 18 to 55 years old
- Minimum weight of 50 kg with BMI between 18 and 34 kg/m^2
- Females must be post-menopausal or have documented hysterectomy or bilateral oophorectomy
CaRMA: Catheter Resistance Monitoring to Predict Catheter-Associated Adverse Events in Children and Adolescents: A Feasibility Study
Eligibility:
- This is a non-therapeutic clinical trial that is only open to St. Jude patients.
- Participant is receiving treatment for any disease at St. Jude.
- Participant is age ≥ 5 years to < 25 years.
- Participant has single or double lumen tunneled CVAD (ports not eligible).
- Participant’s treating clinician does not plan to remove CVAD within 12 weeks.
- Participant has not been previously enrolled in the CaRMA study or had past catheter resistance monitoring.
CCL1034: Chlorhexidine Gluconate Cleansing in Preventing Central Line Associated Bloodstream Infection and Acquisition of Multi-drug Resistant Organisms in Younger Patients With Cancer or Undergoing Donor Stem Cell Transplant
Diseases Treated:
Cancer or allogeneic hematopoietic cell transplantation
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
- Participant > 2 months of age and < 21 years of age at enrollment.
- Participant has or is scheduled to have an external tunneled central venous catheter (CVC) (Broviacs, Hickmans, tunneled percutaneously inserted central PICCs), that is expected to remain in place for an additional > 3 months.
- Participant with a current or previous line infection completed antibiotics > 14 days ago.
CMX351: Experimental Drug Treatment for Adenovirus Infection
Brincidofovir for the Treatment of Serious Adenovirus Infection or Disease
Diseases Treated:
Eligibility:
- 2 months old or older
- Diagnosed with adenovirus (AdV) infection
- Has symptoms related to AdV infection
- Able to take and absorb oral medication
- No previous treatment with brincidofovir (BCV)
ELVIS: Two Part Study to Study Pharmacokinetics, Safety, and Antiviral Activity of Elvitegravir (EVG) Administered With a PI/r Background Regimen for ARV Treatment-Experienced Pediatric Subjects
A Phase 2/3 multicenter, Open-Label, Multicohort, Two-Part Study Evaluating the Pharmacokinetics (PK), Safety, and Antiviral Activity of Elvitegravir (EVG) Administered with a Background Regimen (BR) Containing a Ritonavir-Boosted Protease Inhibitor (PI/r) in HIV-1 Infected, Antiretroviral Treatment-Experienced Pediatric Subjects
Diseases Treated:
Eligibility:
- Participant does not have life expectancy of less than 1 year.
- Participant does not have history of significant drug sensitivity or drug allergy.
- Participant is not participating in any other clinical trial without prior approval from sponsor while participating in this trial.
- Participant does not have an ongoing serious infection requiring systemic antibiotic therapy at the time of screening.
ETHEL: Ethanol Lock Therapy for Treatment and Secondary Prophylaxis of Central Line-Associated Bloodstream Infection
A Double-Blind, Randomized, Placebo-Controlled, Trial of Ethanol Lock Therapy for Treatment and Secondary Prophylaxis of Central Line Associated Bloodstream Infection (CLABSI) in Children and Adolescents
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
- Participant is ≥ 6 months and < 25 years of age and is ≥ 5 kg.
- Participant has new diagnosis of central line associated blood stream infection with a silicone catheter (ports, and Broviac or Hickman lines will be eligible).
- Participant has not received ELT in the preceding 2 weeks.
- Participant does not have multiple long-term central lines.
FLUTRAN: Flu Vaccine Dose Comparison in Children Who Have Had Stem Cell Transplants
Comparison of High vs. Standard Dose Flu Vaccine in Pediatric Stem Cell Transplant Recipients
Diseases Treated:
Influenza
Eligibility:
- At least 3 years old and younger than 17
- Allogeneic hematopoietic stem cell transplant recipient
- At least 3 and not more than 35 months after transplant
- Platelet count of at least 30,000
FLUVIT: A Double-Blind Randomized, Placebo Controlled Study of Antibody Induction By Vitamin Supplementation At The Time Of Influenza Virus Vaccination In Children
Eligibility:
- Participant is age two (2) to eight (8) years inclusive at the time of enrollment.
- Participant is not currently using investigational or immunosuppressive drugs (e.g. steroids) at the time of enrollment.
- Participant is not currently taking a daily (routine) Vitamin A, D or multi-vitamin. Note: Participant who report occasional or sporadic vitamin use will be allowed to enroll.
GS1269: Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 Infected Children and Adolescents Virologically Suppressed on a 2-NRTI-Containing Regimen
A Phase 2/3, Open-Label Multi- Cohort Switch Study to Evaluate Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 Infected Children and Adolescents Virologically Suppressed on a Tenofovir Disoproxil Fumarate (TDF)-Containing Regimen, Initial Version, June 23, 2014
Diseases Treated:
Eligibility:
- Participant is HIV-1 infected male or female aged six (6) to less than eight-teen (18) years of age at Baseline.
- Participant is currently on a stable 2-NRTI (TDF containing) regimen that includes a protocol specified 3rd ARV agent for greater than or equal to six (6) consecutive months prior to screening.
- Participant does not have an acquired immunodeficiency syndrome (AIDS) indicator condition with onset within thirty (30) days prior to screening.
IMPAACT2002: Behavioral Therapy and Medication for Depression among Youth with HIV
Combined Cognitive Behavioral Therapy and a Medication Management Algorithm for Treatment of Depression among Youth Living with HIV in the U.S.
Diseases Treated:
Depression
Eligibility:
- 12 to 24 years old
- Receiving mental health or HIV-related care at participating IMPAACT site
- HIV-positive
- Diagnosis of nonpsychotic depression
- Current depressive symptoms that warrant intervention
- Reads and speaks English
INMED: Investigation of Incentives to Promote Medication Adherence Among HIV-Infected Adolescents on Antiretroviral Therapy.
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.- Participant is > 16 and < 24 years of age.
- Participant is diagnosed with HIV.
- Participant is aware of his/her HIV diagnosis.
- Participant understands either written or spoken English.
ORIOME: Mouth and Nose Microorganisms in Childhood Cancer Patients
The Oronasal Microbiota in Pediatric Oncology Patients
Diseases Treated:
Non-Therapeutic
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
- Between 4 and 21 years old
- Newly confirmed diagnosis of acute myeloid leukemia (AML) or scheduled to receive conditioning for allogeneic hematopoietic stem cell transplantation within seven days
- Receiving treatment at St. Jude Children’s Research Hospital
P1093: Safety of and Immune Response to Dolutegravir in HIV-1 Infected Infants, Children, and Adolescents
Phase I/II, Multi-Center, Open-Label Pharmacokinetic, Safety, Tolerability and Antiviral Activity of Dolutegravir, a Novel Integrase Inhibitor, in Combination Regimens in HIV-1 Infected Infants, Children and Adolescents
Diseases Treated:
Eligibility:
- At least 4 weeks old but younger than 18 years old
- Confirmed HIV-1 infection
- Current or past treatment with HIV medications (Children younger than 2 years old may be eligible even if they have not been treated with HIV medications.)
SENDAI: A Phase I Study of Unmodified Live Intranasal Sendai Virus Vaccine in Children and Toddlers: Assessment of Safety and Immunogenicity
Eligibility:
- Child is greater than or equal to twelve (12) months and less than twenty-four (24) months.
- Child has adequate blood, liver and kidney function.
- Child has no history of lung disease, asthma, and hospitalization for respiratory illness, immunodeficiency, sickle cell disease, or any other serious underlying condition.
-
Featured Trial
VENAML: Chemotherapy Combined with Venetoclax in Children with Refractory or Relapsed Acute Myeloid Leukemia
Diseases Treated:
Acute myeloid leukemia (AML), acute undifferentiated leukemia, mixed phenotype acute leukemia
Eligibility:
- Diagnosis of relapsed or refractory acute myeloid leukemia (AML), acute undifferentiated leukemia or mixed phenotype acute leukemia
- At least 2 years old and younger than 22 years old
- Able to swallow pills
- Recovered from acute effects of prior therapy and no evidence of graft-versus-host disease (GVHD)
- Adequate liver, kidney and heart functions
ALLR18: Therapy for Pediatric Relapsed or Refractory Precursor B-Cell Acute Lymphoblastic Leukemia and Lymphoma
A Phase II Study of Therapy for Pediatric Relapsed or Refractory Precursor B-Cell Acute Lymphoblastic Leukemia and Lymphoma
Diseases Treated:
Relapsed or refractory precursor B-cell acute lymphoblastic leukemia and lymphoma
Eligibility:
- B-cell acute lymphoblastic leukemia or lymphoblastic lymphoma that has:
- Come back after treatment the first time
- Did not respond to treatment the first time
- Less than 22 years of age
- Does not have HIV or hepatitis B infection
ALTE1631: Web-based Exercise Study for Children and Adolescents with Acute Lymphoblastic Leukemia
Web-based Physical Activity Intervention among Children and Adolescents with Acute Lymphoblastic Leukemia
Diseases Treated:
Eligibility:
This is a non-therapeutic clinical trial open to patients receiving treatment at a Children’s Oncology Group (COG)-affiliated institution.
- At least 8 years old and younger than 16 years old
- Newly diagnosed acute lymphoblastic leukemia (ALL), in first remission
- Completed chemotherapy within past 90 days
- Performance status corresponding to ECOG scores of 0, 1, 2
- Fewer than 420 minutes of moderate to vigorous physical activity (MVPA) over the last week
- Access to smart phone (Android 4.3 or later, iOS 7.1 or later or computer with connection to the internet)
- Able to write and read English (patient and at least one parent/guardian)
- Not pregnant
AML16: Epigenetic Priming in Patients with Acute Myeloid Leukemia
Phase II Trial of Epigenetic Priming in Patients with Newly Diagnosed Acute Myeloid Leukemia
Diseases Treated:
Eligibility:
- Diagnosis of one of the following:
- Acute myeloid leukemia (AML)
- 5% to 20% marrow myeloblasts and evidence of a clonal de novo AML genetic abnormality
- Myeloid sarcoma
- High grade myelodysplastic syndrome (MDS) with greater than 5% blasts
- Treatment-related myeloid neoplasms, including AML and MDS
- 28 days to 21 years old
- No prior therapy, except for one dose of intrathecal therapy and the use of hydroxyurea or low-dose cytarabine
- Not pregnant
DSCOG: Learning, Behavior and Social Skills in Survivors of Childhood Leukemia with Down syndrome
Neurocognitive and Psychosocial Outcomes in Survivors of Childhood Leukemia with Down syndrome
Diseases Treated:
Eligibility:
This is a non-therapeutic clinical trial that is open only to patients who were treated at St. Jude Children’s Research Hospital since 1980 and are currently followed at the hospital.
- St. Jude Children’s Research Hospital patient with acute leukemia (i.e., ALL or AML)
- Trisomy 21 Down syndrome diagnosis
- Completed all cancer therapy at St. Jude since 1980 and at least six months prior to study visit
- English as the primary language
HAPNK1: Blood and Marrow Transplant (BMT) for Children with Leukemia/Lymphoma
Haploidentical Donor Hematopoietic Progenitor Cell and Natural Killer Cell Transplantation with a TLI-Based Conditioning Regimen in Patients with Hematologic Malignancies
Diseases Treated:
Eligibility:
- 21 years and younger
- Does not have a suitable HLA-matched sibling donor or volunteer HLA-matched unrelated donor or is not a candidate for conventional matched donor transplant due to refractory disease
- Has a suitable single haplotype-matched family member donor
- High-risk hematologic malignancy, including certain diagnoses of:
- Acute lymphoblastic leukemia (ALL)
- Acute myeloid leukemia (AML)
- Chronic myelogenous leukemia (CML)
- Myelodysplastic syndrome (MDS)
- Hodgkin lymphoma
- Non-Hodgkin lymphoma
M16-106: Combination Chemotherapy for Relapsed Acute Lymphoblastic Leukemia
Phase I Study of Venetoclax with Navitoclax and Chemotherapy for Relapsed Acute Lymphoblastic Leukemia
Diseases Treated:
Eligibility:
- Acute lymphoblastic leukemia (ALL) that has not responded to treatment or has come back after treatment
- Between 4 and 45 years old
- Weigh at least 20 kg (44 lbs)
- Able to swallow pills
NCBP01: Safety Study of Unlicensed, Investigational Cord Blood Units Manufactured by the NCBP for Unrelated Transplantation
A Multicenter Safety Study of Unlicensed, Investigational Cryopreserved Cord Blood Units (CBUs) manufactured by the National Cord Blood Program (NCBP) and provided for Unrelated Hematopoietic Stem Cell Transplantation of Pediatric and Adult Patients
Diseases Treated:
Leukemia and other blood diseases
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
- Participant is receiving an allogeneic hematopoietic stem cell (HSC) transplant at St. Jude Children's Research Hospital using an unlicensed cord blood unit (CBU).
- Participant may be of any age and either gender.
- Participant has a medical disorder affecting the hematopoietic system that is inherited, acquired, or a result from myeloablative treatment.
- Participant is receiving HPC-CORD BLOOD product manufactured by NCBP (at least one, if the graft contains more than one units).
PANAML: Panobinostat, Fludarabine and Cytarabine in Patients with AML or MDS
A Phase I and Dose Expansion Cohort Study of Panobinostat in Combination with Fludarabine and Cytarabine in Pediatric Patients with Refractory or Relapsed Acute Myeloid Leukemia or Myelodysplastic Syndrome
Diseases Treated:
Acute myeloid leukemia (AML), myelodysplastic syndrome (MDS)
Eligibility:
- Diagnosis of AML or MDS that has come back or did not respond to chemotherapy
- 21 years of age or younger at time of enrollment
- Able to swallow capsules
- Recovered from side effects of previous cancer therapy
REF2HCT: Haploidentical Bone Marrow Transplant for Leukemia and Lymphoma
Provision of TCRγδ T Cells and Memory T Cells plus Selected Use of Blinatumomab in Naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies Relapsed or Refractory despite Prior Transplantation
Diseases Treated:
Eligibility:
- 21 years old and younger
- Diagnosed with one of the following that has come back or did not improve after bone marrow transplant
- Acute lymphoblastic leukemia (ALL)
- Acute myeloid leukemia
- Myeloid sarcoma
- Chronic myeloid leukemia (CML)
- Juvenile myelomonocytic leukemia (JMML)
- Myelodysplastic syndrome (MDS)
- Non-Hodgkin lymphoma (NHL)
- Has a family member who is a suitable stem cell donor
SELHEM: Selinexor With Fludarabine and Cytarabine for Treatment of Refractory or Relapsed Leukemia or Myelodysplastic Syndrome
Phase I/II Study of the Selective Inhibitor of Nuclear Export Selinexor (KPT-330) in Combination with Fludarabine and Cytarabine in Patients with Refractory or Relapsed Leukemia or Myelodysplastic Syndrome
Diseases Treated:
Relapsed or refractory leukemia or hematologic malignancies
Eligibility:
(Phase II)
- 21 years of age or younger
- Acute myeloid leukemia (AML)
- No history of HIV infection
SJBC3: Mature B-cell Lymphoma and Leukemia Study III
Risk-Adapted Therapy in Treating Young Patients with Mature B-Cell Lymphoma or Leukemia
Diseases Treated:
Eligibility:
- 21 years of age or younger
- Newly diagnosed mature B-cell non-Hodgkin lymphoma and leukemia
- No previous treatment (no more than 72 hours of steroids, one intrathecal chemotherapy treatment, and/or emergency radiation)
TINI: Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL)
Diseases Treated:
Acute lymphoblastic leukemia (ALL)
Eligibility:
- Newly diagnosed ALL
- 1 year of age or younger at the time of diagnosis
- Has not had any — or has had limited — prior therapy
- Does not have mature B-cell ALL, acute myeloid leukemia (AML) or Down syndrome
TOT17: Total Therapy for Children with Acute Lymphoblastic Leukemia and Lymphoma
Total Therapy Study 17 for Newly Diagnosed Patients with Acute Lymphoblastic Leukemia and Lymphoma
Diseases Treated:
Eligibility:
- Diagnosis of B-cell or T-cell acute lymphoblastic leukemia (ALL) or acute lymphoblastic lymphoma (LLy)
- 1 to 18 years old
- No prior therapy or limited prior therapy
VENAML: Chemotherapy Combined with Venetoclax in Children with Refractory or Relapsed Acute Myeloid Leukemia
A Phase I and Expansion Cohort Study of Venetoclax in Combination with Chemotherapy in Pediatric Patients with Refractory or Relapsed Acute Myeloid Leukemia
Diseases Treated:
Acute myeloid leukemia (AML), acute undifferentiated leukemia, mixed phenotype acute leukemia
Eligibility:
- Diagnosis of relapsed or refractory acute myeloid leukemia (AML), acute undifferentiated leukemia or mixed phenotype acute leukemia
- At least 2 years old and younger than 22 years old
- Able to swallow pills
- Recovered from acute effects of prior therapy and no evidence of graft-versus-host disease (GVHD)
- Adequate liver, kidney and heart functions
-
BMTFU: Protocol for Collecting Long-Term Follow-Up Data on Recipients of Hematopoietic Stem Cell Transplant
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
CCSS: Childhood Cancer Survivor Study
Diseases Treated:
Childhood cancer incidence and survival
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
- Newly diagnosed with cancer between January 1, 1970, and December 31, 1996
- Survival five years from diagnosis
- Age less than 21 years at the time of diagnosis of cancer
- English or Spanish speaking and living in the United States or Canada at the time of diagnosis
FRAILTY: A Longitudinal Assessment of Frailty in Young Adult Survivors of Childhood Cancer
Diseases Treated:
Long-term effects of childhood cancer
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
- Participant is enrolled on the SJLIFE protocol
- Participant completed a baseline SJLIFE assessment between 4 and 6 years prior to FRAILTY enrollment.
- Participant’s age was between the ages of 18-45 when baseline SJLIFE assessment was completed.
- Participant is not currently receiving treatment for cancer.
LACOUT: Lactation Outcomes among Survivors of Pediatric Cancer
Eligibility:
This is a non-therapeutic clinical trial open to St. Jude patients only.
Participant is a St. Jude Life or ACT (After Completion of Therapy) patient.
LDTAM: Low-Dose Tamoxifen Citrate in Reducing Breast Cancer Risk in Radiation-Induced Cancer Survivors
Low-dose Tamoxifen in Hodgkin Lymphoma Survivors for Breast Cancer Risk Reduction: A Phase IIB Randomized Placebo-Controlled Trial
Diseases Treated:
For survivors of Hodgkin lymphoma
Eligibility:
- Females, 25 years of age or older.
- Participant does not plan to become pregnant in the next 2 years and is not currently breast feeding.
LTE1621: Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Heart Failure (PREVENT-HF): A Phase 2B Randomized Placebo-Controlled (Carvedilol) Trial
Diseases Treated:
Cancer
Eligibility:
- Younger than 21 years old at time of cancer diagnosis
- Weigh ≥ 40 Kg
- Lifetime cumulative anthracycline dose prior to age 22: total dose ≥ 250 mg/m2 DOXOrubicin equivalent without the protection of dexrazoxane (Zinecard) therapy
- Completed cancer treatment at least 2 years prior to study enrollment
NEULS: Risk of Psychopathology and Neurocognitive Impairment in Leukemia Survivors
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
- Participant was enrolled on SJCRH TOTXV ALL protocol (or Best Clinical Management that followed the same treatment provided in the TOTXV protocol)
- Minimum of five years post diagnosis of ALL
- Minimum age of 8.0 years at time of follow-up evaluation
ONFUNC: Functional Outcomes For Children, Adolescents, and Young Adults With Osteonecrosis Following Hip Core Decompression
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
- Participant has a diagnosis of osteonecrosis and a hematologic malignancy or sickle cell disease.
- Participant is a candidate for hip core decompression surgery.
- Participant is 8 to 29 years of age.
PREVENT: Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Congestive Heart Failure (PREVENT-CHF): A Phase IIB Randomized Placebo-Controlled Trial
Diseases Treated:
Congestive heart failure
Eligibility:
- Participant is > 16 years of age.
- Participant had cancer diagnosis < 21 years of age.
- Participant has lifetime cumulative anthracycline dose > 300 mg/m2.
- Participant is > 2 years since completion of treatment for cancer.
PTSARC: Physical Therapy in Young Patients With Lower Extremity Malignancies Before Surgery
Effects of Preoperative Physical Therapy in Adolescents and Young Adults Diagnosed with a Lower Extremity Malignancy
Diseases Treated:
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
- Please see clinical trial for full inclusion and exclusion eligibility criteria.
REPS: Impact of Resistance Training–Protein Supplementation on Lean Muscle Mass in Childhood Cancer Survivors
Diseases Treated:
Long-term effects of childhood cancer
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
- Currently enrolled on the SJLIFE protocol
- 18 to 49 years old
- At least 10 years post first cancer diagnosis
- Lives within a 45-minute drive of a Greater Memphis Area ATC Fitness Center
- Speaks English
- Low lean mass defined as either:
- Body fat content of at least 25% in males or at least 35% in females OR
- Age and sex-specific Relative Lean Muscle Mass Standard Deviation score <-1.0
SJLIFE: Establishment of a Lifetime Cohort of Adults Surviving Childhood Cancer
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
- Participant was diagnosed with a childhood cancer which was treated or followed by St. Jude Children's Research Hospital
- Participant completed treatment for disease at least ten years prior to entry in this study
- Participant is willing to return to St. Jude for periodic evaluation
SJLTFU: Protocol for Collecting Data on Childhood Cancer Survivors
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
- All patients being followed or treated at St. Jude Children’s Research Hospital for the diagnosis of childhood cancer
- Patient has not been permanently discharged from care and follow-up
-
Featured Trial
HLHR13: Brentuximab Vedotin, Combination Chemotherapy, and Radiation Therapy in Treating Younger Patients with Stage IIB-IVB Hodgkin Lymphoma
Diseases Treated:
High-risk Hodgkin lymphoma
Eligibility:
- Has high-risk Hodgkin lymphoma
- 18 years of age or younger
- Has not received previous treatment for Hodgkin lymphoma
ALLR18: Therapy for Pediatric Relapsed or Refractory Precursor B-Cell Acute Lymphoblastic Leukemia and Lymphoma
A Phase II Study of Therapy for Pediatric Relapsed or Refractory Precursor B-Cell Acute Lymphoblastic Leukemia and Lymphoma
Diseases Treated:
Relapsed or refractory precursor B-cell acute lymphoblastic leukemia and lymphoma
Eligibility:
- B-cell acute lymphoblastic leukemia or lymphoblastic lymphoma that has:
- Come back after treatment the first time
- Did not respond to treatment the first time
- Less than 22 years of age
- Does not have HIV or hepatitis B infection
APNEA: Sleep Apnea in Hodgkin Lymphoma Survivors Treated with Radiation to the Chest
Obstructive Sleep Apnea in Survivors of Hodgkin Lymphoma Treated with Thoracic Radiation
Diseases Treated:
Eligibility:
This is a non-therapeutic clinical trial that is only open to former St. Jude patients, their family members and friends.
Hodgkin lymphoma survivor
- Current St. Jude LIFE participant, treated with thoracic radiation for Hodgkin lymphoma
- At least 18 years old
- At least 5 years from original diagnosis
Comparison group
- Sibling, parent, relative or friend of a current or former St. Jude patient
- At least 18 years old
EBV201: Immunotherapy for Epstein-Barr Virus-Associated Cancers
Study of Allogeneic Epstein-Barr Virus Cytotoxic T Lymphocytes (EBV-CTLs) in EBV-Associated Viremia or Malignancies
Diseases Treated:
Eligibility:
- Epstein-Barr Virus (EBV) lymphoma or EBV-associated lymphoproliferative disorder
- Primary or acquired immunodeficiency
- Appropriate HLA partially-matched and restricted EBV-Cytotoxic T Lymphocytes (EBV-CTLs)
- No other satisfactory therapies available to treat EBV disease
FAMHL: Genetic Study of Families with Hodgkin Lymphoma
Genetic Study of Families with High Frequency of Hodgkin Lymphoma
Diseases Treated:
Eligibility:
- 21 years of age or younger
- Patient has a parent, sister, brother or child who also has Hodgkin lymphoma
- Patient’s other family members who agree to participate
HAPNK1: Blood and Marrow Transplant (BMT) for Children with Leukemia/Lymphoma
Haploidentical Donor Hematopoietic Progenitor Cell and Natural Killer Cell Transplantation with a TLI-Based Conditioning Regimen in Patients with Hematologic Malignancies
Diseases Treated:
Eligibility:
- 21 years and younger
- Does not have a suitable HLA-matched sibling donor or volunteer HLA-matched unrelated donor or is not a candidate for conventional matched donor transplant due to refractory disease
- Has a suitable single haplotype-matched family member donor
- High-risk hematologic malignancy, including certain diagnoses of:
- Acute lymphoblastic leukemia (ALL)
- Acute myeloid leukemia (AML)
- Chronic myelogenous leukemia (CML)
- Myelodysplastic syndrome (MDS)
- Hodgkin lymphoma
- Non-Hodgkin lymphoma
HLHR13: Brentuximab Vedotin, Combination Chemotherapy, and Radiation Therapy in Treating Younger Patients with Stage IIB-IVB Hodgkin Lymphoma
Adcetris® (Brentuximab Vedotin) Substituting Vincristine in the OEPA/COPDac Regimen [Treatment Group 3 (TG3) of Euro-Net C1] With Involved Node Radiation Therapy for High-Risk Pediatric Hodgkin Lymphoma (HL)
Diseases Treated:
High-risk Hodgkin lymphoma
Eligibility:
- Has high-risk Hodgkin lymphoma
- 18 years of age or younger
- Has not received previous treatment for Hodgkin lymphoma
HOD08: Combination Chemotherapy with or without Radiation Therapy in Treating Young Patients with Favorable-Risk Hodgkin Lymphoma
Reduced Duration Stanford V Chemotherapy With or Without Low-Dose Tailored-Field Radiation Therapy for Favorable Risk Pediatric Hodgkin Lymphoma
Diseases Treated:
Eligibility:
- Diagnosis of early-stage Hodgkin lymphoma
- Hodgkin lymphoma that has not been previously treated
- 21 years of age or younger
LDTAM: Low-Dose Tamoxifen Citrate in Reducing Breast Cancer Risk in Radiation-Induced Cancer Survivors
Low-dose Tamoxifen in Hodgkin Lymphoma Survivors for Breast Cancer Risk Reduction: A Phase IIB Randomized Placebo-Controlled Trial
Diseases Treated:
For survivors of Hodgkin lymphoma
Eligibility:
- Females, 25 years of age or older.
- Participant does not plan to become pregnant in the next 2 years and is not currently breast feeding.
REF2HCT: Haploidentical Bone Marrow Transplant for Leukemia and Lymphoma
Provision of TCRγδ T Cells and Memory T Cells plus Selected Use of Blinatumomab in Naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies Relapsed or Refractory despite Prior Transplantation
Diseases Treated:
Eligibility:
- 21 years old and younger
- Diagnosed with one of the following that has come back or did not improve after bone marrow transplant
- Acute lymphoblastic leukemia (ALL)
- Acute myeloid leukemia
- Myeloid sarcoma
- Chronic myeloid leukemia (CML)
- Juvenile myelomonocytic leukemia (JMML)
- Myelodysplastic syndrome (MDS)
- Non-Hodgkin lymphoma (NHL)
- Has a family member who is a suitable stem cell donor
SJBC3: Mature B-cell Lymphoma and Leukemia Study III
Risk-Adapted Therapy in Treating Young Patients with Mature B-Cell Lymphoma or Leukemia
Diseases Treated:
Eligibility:
- 21 years of age or younger
- Newly diagnosed mature B-cell non-Hodgkin lymphoma and leukemia
- No previous treatment (no more than 72 hours of steroids, one intrathecal chemotherapy treatment, and/or emergency radiation)
TOT17: Total Therapy for Children with Acute Lymphoblastic Leukemia and Lymphoma
Total Therapy Study 17 for Newly Diagnosed Patients with Acute Lymphoblastic Leukemia and Lymphoma
Diseases Treated:
Eligibility:
- Diagnosis of B-cell or T-cell acute lymphoblastic leukemia (ALL) or acute lymphoblastic lymphoma (LLy)
- 1 to 18 years old
- No prior therapy or limited prior therapy
-
CASELEARN: A Qualitative Case Study of the Experiences of Children with Cancer as they Learn about their Diagnosis and Treatment
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
Please see the eligibility section on the clinical trial for full inclusion and exclusion criteria.
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ADV1217: WEE1 Inhibitor MK-1775 and Local Radiation Therapy in Treating Younger Patients With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas
A Phase I Study of MK-1775 (IND#116459) Concurrent with Local Radiation Therapy for the Treatment of Newly Diagnosed Children with Diffuse Intrinsic Pontine Gliomas
Diseases Treated:
Newly diagnosed Diffuse Intrinsic Pontine Glioma (DIPG)
Eligibility:
- Participant is > 36 month and < 21 years of age at the time of study enrollment.
- Participant has newly diagnosed DIPG.
- Participant has a brainstem tumor that was biopsied and proven to be one of the following: anaplastic astrocytoma, glioblastoma, gliosarcoma, or anaplastic mixed glioma.
- Participant has not received any prior chemotherapy, radiation therapy, immunotherapy or bone marrow transplant for the treatment of DIPG. Prior dexamethasone and/or surgery are allowed.
ADV1312: WEE1 Inhibitor MK-1775 and Irinotecan Hydrochloride in Treating Younger Patients With Relapsed or Refractory Solid Tumors
A Phase I/II Study of MK-1775 (AZD1775, IND# 121422) in Combination with Oral Irinotecan In Children, Adolescents, and Young Adults with Relapsed or Refractory Solid Tumors
Diseases Treated:
Relapsed or refractory solid tumors
Eligibility:
- Participant is >12 months and < 21 years of age at the time of study entry.
- Participant has had histologic verification of malignancy at original diagnosis or relapse.
- Participant has serum tumor markers including alpha-fetoprotein or beta-HCG.
- Participant has a relapsed or refractory solid tumor.
ADV1414: Phase I Study of Selinexor to Treat Patients with Recurrent and Refractory Pediatric Solid Tumors
A Phase I Study of Selinexor (KPT-330, IND #125052), a Selective XPO1 Inhibitor, in Recurrent and Refractory Pediatric Solid Tumors, Including CNS Tumors
Diseases Treated:
Eligibility:
- Diagnosis of solid tumor that is resistant to other anticancer therapy or has come back after therapy. Includes lymphoma and central nervous system (CNS) tumors that may or may not require surgery.
- Fully recovered from the acute toxic effects of all prior anticancer therapy
- At least 1 but not more than 21 years of age
- Able to swallow tablets whole
ADV1416: A Study of Ramucirumab in Children with Solid Tumors and Brain Tumors
A Phase I Study of Ramucirumab, a Human Monoclonal Antibody Against the Vascular Endothelial Growth Factor-2 (VEGFR-2) Receptor in Children with Refractory Solid Tumors, Including CNS Tumors
Diseases Treated:
Eligibility:
- 12 months old or older and younger than 21 years old
- Diagnosis:
- Part A - Non-central nervous system (CNS) tumor that returned after treatment or did not respond to treatment
- Part B – CNS tumor that returned after treatment or did not respond to treatment
- No other proven therapy options
ADVL1513: Entinostat for Children with Recurrent or Refractory Solid Tumors
A Phase I Study of Entinostat, an Oral Histone Deacetylase Inhibitor, in Pediatric Patients with Recurrent or Refractory Solid Tumors, including CNS Tumors and Lymphoma
Diseases Treated:
Solid Tumor, CNS Tumor, Lymphoma
Eligibility:
- 12 months to 21 years old
- Able to swallow whole tablets
- Diagnosis of recurrent or refractory solid tumor, including CNS tumor and lymphoma
ADVL1515: Prexasertib for Children with Recurrent or Refractory Solid Tumors
A Phase I Study of LY2606368 (prexasertib mesylate monohydrate), A CHK1/2 Inhibitor, in Pediatric Patients with Recurrent or Refractory Solid Tumors, including CNS Tumors
Diseases Treated:
Solid Tumor, CNS Tumor
Eligibility:
- 12 months to 21 years old
- Diagnosis of recurrent or refractory solid tumor, including CNS tumor
ALLR18: Therapy for Pediatric Relapsed or Refractory Precursor B-Cell Acute Lymphoblastic Leukemia and Lymphoma
A Phase II Study of Therapy for Pediatric Relapsed or Refractory Precursor B-Cell Acute Lymphoblastic Leukemia and Lymphoma
Diseases Treated:
Relapsed or refractory precursor B-cell acute lymphoblastic leukemia and lymphoma
Eligibility:
- B-cell acute lymphoblastic leukemia or lymphoblastic lymphoma that has:
- Come back after treatment the first time
- Did not respond to treatment the first time
- Less than 22 years of age
- Does not have HIV or hepatitis B infection
AOST1421: Combination Drug Therapy to Treat Patients with Recurrent Osteosarcoma
A Phase II Study of Human-Mouse Chimeric Anti-Disialoganglioside Monoclonal Antibody ch14.18 (Dinutuximab) in Combination with Sargramostim (GM-CSF) in Patients with Recurrent Osteosarcoma
Diseases Treated:
Eligibility:
- Younger than 30 years old
- Original diagnosis of osteosarcoma
- Osteosarcoma has come back in the lungs after original treatment
- Lung tumors have been removed surgically within the last 4 weeks before enrolling in the study
BMNIRN: Talazoparib Plus Irinotecan With or Without Temozolomide in Children with Refractory or Recurrent Solid Malignancies
A Phase I Study of Talazoparib (BMN 673) Plus Irinotecan With or Without Temozolomide in Children with Refractory or Recurrent Solid Malignancies
Diseases Treated:
Relapsed or refractory solid tumors
Eligibility:
- Participant has refractory or recurrent solid tumor for which there is no standard therapy.
- Participant has had histologic verification of malignancy at original diagnosis or at the time of relapse.
- Participant is twelve (12) months to twenty-five (25) years of age at the time of enrollment on study.
- Participant life expectancy is at least eight (8) weeks.
BRF116: A Study to Determine Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib In Children and Adolescent Subjects
Phase I/IIa, 2-Part, Multi-Center, Single-Arm, Open-Label Study to Determine the Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib in Children and Adolescent Subjects with Advance BRAF V600-Mutation Positive Solid Tumors
Diseases Treated:
Solid tumors, giomas, hystiocytosis
Eligibility:
- Participant is greater or equal to 12 months and less than 18 years at the time of signing the informed consent form.
- Participant has BRAF V600 mutation positive tumor as confirmed in a CLIA-approved laboratory or equivalent
- Participant has recurrent disease, refractory disease, or progressive disease after having received at least one standard therapy for their disease, OR participant has metastatic (or surgically unresectable) melanoma, and is being enrolled for first-line treatment. Melanoma participants with CNS involvement may be enrolled.
CCL0922: Modafinil in Treating Children With Memory and Attention Problems Caused by Cancer Treatment for a Brain Tumor
A Phase II Placebo-Controlled Trial of Modafinil to Improve Neurocognitive Deficits in Children Treated for a Primary Brain Tumor (SCUSF 0901; ACCL0922)
Diseases Treated:
Brain Tumor : Previously treated brain tumors
Eligibility:
- Age is > 6 years and < 17 years & 10 months at the time of study entry.
- Off treatment and progression–free for at least 12 months and less than and equal to 14 years.
- Diagnosis of a primary brain tumor treated with at least one of the following :
- Neurosurgical resection of the brain tumor;
- Cranial irradiation;
- Any chemotherapy to treat the brain tumor
CNS1123: Chemotherapy Followed by Radiation Therapy in Treating Younger Patients With Newly Diagnosed Localized Central Nervous System Germ Cell Tumors
Phase II Trial of Response-Based Radiation Therapy for Patients with Localized Central Nervous System Germ Cell Tumors (CNS GCT)
Diseases Treated:
Newly diagnosed localize primary NGGCT or newly diagnosed localized germinoma
Eligibility:
- Participant is > 3 years and < 21 years at the time of enrollment.
- Participant has newly diagnosed localized primary NGGCT or newly diagnosed localized germinoma (has not spread to other parts of the brain or spine).
- Participant must have adequate bone marrow function.
- Participant must have normal renal and liver function for age.
- NO prior therapy except surgery and/or steroids.
CSqHPV: Vaccine Therapy in Preventing Human Papillomavirus Infection in Younger Cancer Survivors
Quadrivalent Human Papillomavirus (qHPV) Vaccine in Cancer Survivors: Cross Sectional Survey and Phase II Open-Label Vaccine Trial A Consortium for Pediatric Interventional Research
Diseases Treated:
Human papillomavirus
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
Questionnaire phase
- Cancer survivor (9 to 26 years of age at study participation)
- English or Spanish-speaking
Vaccine Phase
- Survey response indicated no prior history of HPV vaccination
- Agrees to return to participating institution for 3 HPV vaccine injections
- Allergy to any component of the HPV vaccine including yeast and aluminum will not be eligible for the study
ED0157: Phase 1 Pediatric PK/PD Study
A Phase I, Open-Label, Single-Dose, Non-Randomized Study to Evaluate Pharmacokinetics and Pharmacodynamics of Edoxaban in Pediatric Patients
Diseases Treated:
For patients at risk for blood clots
Eligibility:
- Participant has a diagnosis requiring anticoagulant therapy.
- Participant has completed their standard anticoagulant therapy.
- Participant is not receiving active therapy for a malignant condition.
- Participant is less than 18 years of age at the time of consent.
- Participant and legal guardian agree to food and drug restrictions during study.
ELVIS: Two Part Study to Study Pharmacokinetics, Safety, and Antiviral Activity of Elvitegravir (EVG) Administered With a PI/r Background Regimen for ARV Treatment-Experienced Pediatric Subjects
A Phase 2/3 multicenter, Open-Label, Multicohort, Two-Part Study Evaluating the Pharmacokinetics (PK), Safety, and Antiviral Activity of Elvitegravir (EVG) Administered with a Background Regimen (BR) Containing a Ritonavir-Boosted Protease Inhibitor (PI/r) in HIV-1 Infected, Antiretroviral Treatment-Experienced Pediatric Subjects
Diseases Treated:
Eligibility:
- Participant does not have life expectancy of less than 1 year.
- Participant does not have history of significant drug sensitivity or drug allergy.
- Participant is not participating in any other clinical trial without prior approval from sponsor while participating in this trial.
- Participant does not have an ongoing serious infection requiring systemic antibiotic therapy at the time of screening.
EWS1221: Phase III Study of Ganitumab with Chemotherapy for Patients with Metastatic Ewing Sarcoma
Randomized Phase III Trial Evaluating the Addition of the IGF-1R Monoclonal Antibody Ganitumab (AMG 479, NSC# 750008, IND# 120449) to Multiagent Chemotherapy for Patients with Newly Diagnosed Metastatic Ewing Sarcoma
Diseases Treated:
Eligibility:
- Younger than or equal to 50 years old
- Diagnosis of Ewing sarcoma or peripheral primitive neuroectodermal tumor (PNET) arising from bone or soft tissue and with metastatic disease involving lung, bone, bone marrow or other metastatic site
EZH102: Tazemetostat in Children and Young Adults with Synovial Sarcoma or INI1-Negative Tumors
A Phase I Study of the EZH2 Inhibitor Tazemetostat in Pediatric Subjects with Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma
Diseases Treated:
- Rhabdoid tumor
- Synovial sarcoma
- INI 1-negative tumor
Eligibility:
- Between 6 months and 21 years old
- Relapsed or refractory rhabdoid tumors, INI1-negative tumors or synovial sarcoma
HLHR13: Brentuximab Vedotin, Combination Chemotherapy, and Radiation Therapy in Treating Younger Patients with Stage IIB-IVB Hodgkin Lymphoma
Adcetris® (Brentuximab Vedotin) Substituting Vincristine in the OEPA/COPDac Regimen [Treatment Group 3 (TG3) of Euro-Net C1] With Involved Node Radiation Therapy for High-Risk Pediatric Hodgkin Lymphoma (HL)
Diseases Treated:
High-risk Hodgkin lymphoma
Eligibility:
- Has high-risk Hodgkin lymphoma
- 18 years of age or younger
- Has not received previous treatment for Hodgkin lymphoma
HOD08: Combination Chemotherapy with or without Radiation Therapy in Treating Young Patients with Favorable-Risk Hodgkin Lymphoma
Reduced Duration Stanford V Chemotherapy With or Without Low-Dose Tailored-Field Radiation Therapy for Favorable Risk Pediatric Hodgkin Lymphoma
Diseases Treated:
Eligibility:
- Diagnosis of early-stage Hodgkin lymphoma
- Hodgkin lymphoma that has not been previously treated
- 21 years of age or younger
HODLP: First International Inter-Group Study for Nodular Lymphocyte Predominant Hodgkin Lymphoma in Children and Adolescents
Surgery Alone, Surgery With Cyclophosphamide, Vinblastine, and Prednisolone (CVP), or CVP Alone in Treating Young Patients With Stage IA or Stage IIA Nodular Lymphocyte-Predominant Hodgkin Lymphoma
Diseases Treated:
Lymphocyte predominant Hodgkin lymphoma
Eligibility:
- Diagnosis of early-stage lymphocyte-predominant Hodgkin lymphoma (LPHL)
- LPHL that has not been previously treated with chemotherapy or radiation therapy
- 18 years of age or younger
iRET: Intravitreal Chemotherapy for Children with Retinoblastoma
Intravitreal Carboplatin for the Treatment of Participants with Recurrent or Refractory Intraocular Reintoblastoma
Diseases Treated:
Eligibility:
- Age 17 or younger
- Diagnosis of retinoblastoma that did not go away with treatment or came back after treatment
LDTAM: Low-Dose Tamoxifen Citrate in Reducing Breast Cancer Risk in Radiation-Induced Cancer Survivors
Low-dose Tamoxifen in Hodgkin Lymphoma Survivors for Breast Cancer Risk Reduction: A Phase IIB Randomized Placebo-Controlled Trial
Diseases Treated:
For survivors of Hodgkin lymphoma
Eligibility:
- Females, 25 years of age or older.
- Participant does not plan to become pregnant in the next 2 years and is not currently breast feeding.
LOXO-TRK: Testing Larotrectinib (LOXO-101) in Children with Advanced Solid Tumors or Brain Tumors
A Phase 1/2 Study of the Oral TRK Inhibitor LOXO-101 in Pediatric Patients with Advanced Solid or Primary Central Nervous System Tumors (LOXO-TRK-15003)
Diseases Treated:
Solid Tumors, Central Nervous System Tumors
Eligibility:
Phase 1
- Birth through 21 years of age with locally advanced or metastatic solid tumor or primary CNS tumor that has progressed or was nonresponsive to therapy and for which there is no standard or available curative therapy, OR
- Infants from birth and older with diagnosis of malignancy and with documented NTRK fusion that has progressed or was nonresponsive to therapy and for which there is no standard or available curative therapy, OR
- Patients with locally advanced infantile fibrosarcoma who would require disfiguring surgery or limb amputation to achieve complete surgical resection
Phase 2
- Infants from birth and older at C1D1 with locally advanced or metastatic infantile fibrosarcoma OR
- Birth through 21 years old at C1D1 with locally advanced or metastatic solid tumor or primary CNS tumor that has relapsed, progressed or was not responsive to therapy and for which no standard or available curative therapy with a NTRK gene funsion OR
- More than 21 years old with tumor diagnosis typical of a pediatric patient and an NTRK fusion
LTE1621: Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Heart Failure (PREVENT-HF): A Phase 2B Randomized Placebo-Controlled (Carvedilol) Trial
Diseases Treated:
Cancer
Eligibility:
- Younger than 21 years old at time of cancer diagnosis
- Weigh ≥ 40 Kg
- Lifetime cumulative anthracycline dose prior to age 22: total dose ≥ 250 mg/m2 DOXOrubicin equivalent without the protection of dexrazoxane (Zinecard) therapy
- Completed cancer treatment at least 2 years prior to study enrollment
MEK116: Study to Investigate Safety, Pharmacokinetic (PK), Pharmacodynamic (PD) and Clinical Activity of Trametinib in Subjects With Cancer or Plexiform Neurofibromas and Trametinib in Combination With Dabrafenib in Subjects With Cancers Harboring V600 Mutations
An Open- Label, Dose Escalation, Phase I/II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the MEK Inhibitor Trametinib in Children and Adolescent Subjects with Cancer or Plexiform Neurofibromas and Trametinib in Combination with Dabrafenib in Children and Adolescents with Cancers Harboring V600 Mutations.
Diseases Treated:
Relapsed or refractory solid tumor
Eligibility:
- Participant is at least one month old and younger than 18 years old at the time of signing the informed consent (in Part A, participants < 2 years of age are not included).
- Participant has a histologically confirmed solid tumor
- Participant has a disease that is relapsed or refractory to all potentially curative standard treatment regimens, or has a disease for which there is no standard treatment regimen that is potentially curative.
MEKPEM: A Phase I/II Study of Pembrolizumab (MK-3475) in Children with Advanced Melanoma or a PD-L1 Positive Advanced Relapsed or Refractory Solid Tumor or Lymphoma
(Merck study KEYNOTE-051, IND# 110,080, dated 10-15/2014). EudraCT NUMBER: 2014-002950-38
Diseases Treated:
Advanced melanoma or PD-L1 positive advanced relapsed or refractory solid tumor or lymphoma
Eligibility:
- Participant has advanced melanoma or PD-L1 positive advanced, relapsed or refractory solid tumor or lymphoma
- Participant of child bearing potential has a negative pregnancy test 72 hours prior to medication administration
- Participant has appropriate liver and kidney function
MEMCRT: Memantine to Prevent Thinking Problems in Children Receiving Radiation for Certain Brain Tumors
Memantine for Prevention of Cognitive Late Effects in Pediatric Patients Receiving Cranial Radiation Therapy for Localized Brain Tumors: A Pilot Study
Diseases Treated:
Eligibility:
- Between 6 and 21 years old
- Diagnosis of localized low-grade glioma, craniopharyngioma, ependymoma or germ cell tumor
- Initiating focal cranial radiation therapy (photon or proton)
- Able to swallow pills
- Participant and parent/legal guardian speak, read and understand English
- Normal ECG and laboratory tests
- Adequate vision and hearing
NB2012: Therapy for Children with Advanced Stage High-Risk Neuroblastoma
Anti-GD2 Monoclonal Antibody Hu14.18K322A and Combination Chemotherapy before Autologous Stem Cell Transplant and Radiation Therapy in Treating Younger Patients with Previously Untreated High-Risk Neuroblastoma
Diseases Treated:
Eligibility:
- Younger than 19 years old
- Newly diagnosed, advanced stage, high-risk neuroblastoma
- Histologic proof of neuroblastoma or positive bone marrow for tumor cells with increased urine catecholamine
- Adequate kidney and liver functions
NOTCHES1: Novel Therapies in Children with Sickle Cell Disease
A Phase IIa, Open-label, Single and Multiple Dose Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Exploratory Treatment Effect of GBT440 in Adolescents with Sickle Cell Disease
Diseases Treated:
Eligibility:
- 12 to 17 years old
- Diagnosis of sickle cell disease
- Able to swallow capsules
P1093: Safety of and Immune Response to Dolutegravir in HIV-1 Infected Infants, Children, and Adolescents
Phase I/II, Multi-Center, Open-Label Pharmacokinetic, Safety, Tolerability and Antiviral Activity of Dolutegravir, a Novel Integrase Inhibitor, in Combination Regimens in HIV-1 Infected Infants, Children and Adolescents
Diseases Treated:
Eligibility:
- At least 4 weeks old but younger than 18 years old
- Confirmed HIV-1 infection
- Current or past treatment with HIV medications (Children younger than 2 years old may be eligible even if they have not been treated with HIV medications.)
PANAML: Panobinostat, Fludarabine and Cytarabine in Patients with AML or MDS
A Phase I and Dose Expansion Cohort Study of Panobinostat in Combination with Fludarabine and Cytarabine in Pediatric Patients with Refractory or Relapsed Acute Myeloid Leukemia or Myelodysplastic Syndrome
Diseases Treated:
Acute myeloid leukemia (AML), myelodysplastic syndrome (MDS)
Eligibility:
- Diagnosis of AML or MDS that has come back or did not respond to chemotherapy
- 21 years of age or younger at time of enrollment
- Able to swallow capsules
- Recovered from side effects of previous cancer therapy
PBTC29: Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
A Phase I and Phase II and Re-treatment Study of AZD6244 for Recurrent or Refractory Low Grade Glioma (PBTC-029)
Diseases Treated:
Eligibility:
- Participant is ≥ 3 but ≤ 21 years of age at registration.
- Participant has a diagnosis of low grade glioma (Grades I & II) or optic pathway gliomas with clinical and/or radiographic evidence of progression.
- Participant received last fraction of local irradiation to the primary tumor ≥ 12 weeks prior to registration, or does not apply.
PBTC39: Peginterferon Alfa-2b in Treating Younger Patients With Craniopharyngioma That is Recurrent or Cannot Be Removed By Surgery
Phase II Study of Peginterferon alfa-2b (PEGIntron) for Pediatric Patients with Unresectable or Recurrent Craniopharyngioma (PBTC-039)
Diseases Treated:
Unresectable or recurrent craniopharyngioma
Eligibility:
- Participant has a histologically verified diagnosis of craniopharyngioma.
- Participant has recovered from acute toxicities of all prior therapy before entering this study.
- Participant has not received prior interferon, either systemic or into the tumor cyst.
- Participant does not have evidence of metastatic tumor.
PBTC42: Palbociclib Isethionate in Treating Younger Patients With Recurrent, Progressive, or Refractory Central Nervous System Tumors
Phase I Study of CDK 4-6 Inhibitor PD-0332991 (palbociclib; IBRANCE) in Children with Recurrent, Progressive or Refractory Central Nervous System Tumors
Diseases Treated:
Retinoblastoma protein 1 (Rb1) positive recurrent, progressive, or refractory central nervous system tumors
Eligibility:
- Between 4 and 21 years old
- Able to swallow capsules
- Rb1-positive recurrent, progressive or refractory central nervous system (CNS) tumor or DIPG
- Stable neurological deficit for at least 1 week prior to enrollment
- Last dose of known myelosuppressive anticancer chemotherapy at least 3 weeks prior to enrollment
- Last fraction of focal irradiation > 2 weeks prior to enrollment
PBTC47: A Clinical Trial of the Drug, Panobinostat, in Children with Brain Tumors
Trial of Panobinostat in Children with Diffuse Intrinsic Pontine Glioma (DIPG)
Diseases Treated:
Diffuse Intrinsic Pontine Glioma (DIPG)
Eligibility:
- Diagnosis of progressive diffuse intrinsic pontine glioma (DIPG) or an increase in the bi-dimensional measurement or the appearance of a new tumor lesion since diagnosis
- At least 2 but not more than 22 years old
- Able to swallow capsules whole
PMVOC: Pain Management of Vaso-Occlusive Crisis in Children and Young Adults with Sickle Cell Disease
Diseases Treated:
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
PNOC001: Phase II Study of Everolimus for Recurrent or Progressive Low-Grade Gliomas in Children (CC #120817)
Diseases Treated:
Recurrent or progressive low grade gliomas (brain tumors)
Eligibility:
- Participant is three (3) to twenty-one (21) years of age.
- Patient has refractory, progressive or recurrent confirmed low-grade glioma (WHO grade I or II) that was confirmed histologically at initial diagnosis.
- Participant received his or her last dose of myelosuppressive anticancer chemotherapy at least three (3) weeks prior to study registration, or at least six (6) weeks if nitrosourea.
- Participant received his or her last dose of other investigational or biological agent more than seven (7) days prior to study entry.
PREVENT: Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Congestive Heart Failure (PREVENT-CHF): A Phase IIB Randomized Placebo-Controlled Trial
Diseases Treated:
Congestive heart failure
Eligibility:
- Participant is > 16 years of age.
- Participant had cancer diagnosis < 21 years of age.
- Participant has lifetime cumulative anthracycline dose > 300 mg/m2.
- Participant is > 2 years since completion of treatment for cancer.
REF2HCT: Haploidentical Bone Marrow Transplant for Leukemia and Lymphoma
Provision of TCRγδ T Cells and Memory T Cells plus Selected Use of Blinatumomab in Naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies Relapsed or Refractory despite Prior Transplantation
Diseases Treated:
Eligibility:
- 21 years old and younger
- Diagnosed with one of the following that has come back or did not improve after bone marrow transplant
- Acute lymphoblastic leukemia (ALL)
- Acute myeloid leukemia
- Myeloid sarcoma
- Chronic myeloid leukemia (CML)
- Juvenile myelomonocytic leukemia (JMML)
- Myelodysplastic syndrome (MDS)
- Non-Hodgkin lymphoma (NHL)
- Has a family member who is a suitable stem cell donor
REFGCT: A Phase II Study of Two Drugs for Relapsed or Refractory Malignant Germ Cell Tumors
A Phase II Study of Sirolimus and Erlotinib in Recurrent and Refractory Germ Cell Tumors
Diseases Treated:
Refractory and recurrent solid tumors
Eligibility:
- Participant is between 1-25 years old e at the time of enrollment (Note: eligibility up to age 50 years for other participating sites).
- Participant has had histologic verification of an extracranial germ cell tumor that is not a pure teratoma (mature or immature), pure germinoma, or pure seminoma.
- Participant has relapsed or refractory disease following at least two prior platinum-containing chemotherapy regimens.
- Patients must have measurable disease, documented according to RECIST criteria, or evaluable disease with a standard tumor marker (AFP and/or HCG) greater than 10 times the upper limit of normal.
- Other requirements for this study.
RERTEP: Surgery and Second-Course Radiation Therapy in Treating Younger Patients With Recurrent Ependymoma
A Phase II Trial of Surgery and Fractionated Re-irradiation for Recurrent Ependymoma
Diseases Treated:
Recurrent ependymoma
Eligibility:
- Progressive intracranial ependymoma after prior focal irradiation
- At least 1 year old and younger than 21 years old
- Adequate performance status (ECOG less than 3)
- Does not require mechanical ventilation
- Interval from start of initial radiation therapy to enrollment greater than 9 months
RT2CR: Limited Surgery and Proton Beam Radiation Therapy in Treating Younger Patients with Brain Tumors
A Phase II Trial of Limited Surgery and Proton Therapy for Craniopharyngioma and Observation for Craniopharyngioma after Radical Resection
Diseases Treated:
Eligibility:
- 21 years of age or younger
- Diagnosis of craniopharyngioma
- Has not been previously treated with radiation therapy
RT3CR: Proton Therapy for Pediatric Craniopharyngioma
A Phase II Trial of Intensity-Modulated Proton Therapy for Incompletely Resected Craniopharyngioma and Observation for Craniopharyngioma After Radical Resection
Diseases Treated:
Eligibility:
- 21 years old or younger
- Diagnosis of craniopharyngioma
SBRT1: Stereotactic Radiation Therapy for Pediatric Sarcomas
A Phase II Study of Hypofractionated Stereotactic Radiotherapy in the Treatment of Metastatic Pediatric Sarcomas of Bony Sites
Diseases Treated:
Eligibility:
- Participant has histologically or cytologically confirmed diagnosis:
- Nonrhabdomyosarcoma of soft tissue
- Ewing sarcoma
- Osteosarcoma at any site
- Participant must be greater than 3 years of age and < 40 years of age.
- Participant has not had any prior radiotherapy to the treatment site.
SELHEM: Selinexor With Fludarabine and Cytarabine for Treatment of Refractory or Relapsed Leukemia or Myelodysplastic Syndrome
Phase I/II Study of the Selective Inhibitor of Nuclear Export Selinexor (KPT-330) in Combination with Fludarabine and Cytarabine in Patients with Refractory or Relapsed Leukemia or Myelodysplastic Syndrome
Diseases Treated:
Relapsed or refractory leukemia or hematologic malignancies
Eligibility:
(Phase II)
- 21 years of age or younger
- Acute myeloid leukemia (AML)
- No history of HIV infection
SENDAI: A Phase I Study of Unmodified Live Intranasal Sendai Virus Vaccine in Children and Toddlers: Assessment of Safety and Immunogenicity
Eligibility:
- Child is greater than or equal to twelve (12) months and less than twenty-four (24) months.
- Child has adequate blood, liver and kidney function.
- Child has no history of lung disease, asthma, and hospitalization for respiratory illness, immunodeficiency, sickle cell disease, or any other serious underlying condition.
SJATRT: Phase II Study of Alisertib Therapy for Rhabdoid Tumors
Phase II Study of Alisertib as a Single Agent in Recurrent or Progressive Central Nervous System (CNS) Atypical Teratoid Rhabdoid Tumors (ATRT) and Extra-CNS Malignant Rhabdoid Tumors (MRT) and in Combination Therapy in Newly Diagnosed ATRT
Diseases Treated:
Brain Tumor : Recurrent, progressive, or newly diagnosed atypical teratoid rhabdoid brain tumors (ATRT)
Solid Tumor : Progressive extra-CNS malignant rhabdoid solid tumors (MRT)Eligibility:
- Has one of these types of tumors:
- Newly diagnosed atypical teratoid rhabdoid tumors (ATRTs) or synchronous extraneural ATRTs
- ATRTs or malignant rhabdoid tumors (MRTs) that have come back after previous treatment (recurrent disease)
- ATRTs or MRTs that are growing after previous treatment (progressive disease)
- 21 years of age or younger
SJDAWN: Molecular-Based Therapy for Aggressive Brain and Spinal Cord Tumors in Children and Young Adults
Molecularly-Driven Doublet Therapy for All Children with Refractory or Recurrent CNS Malignant Neoplasms and Young Adults with Refractory or Recurrent SHH Medulloblastoma
Diseases Treated:
Brain tumor, medulloblastoma, ependymoma
Eligibility:
Ages for Study Enrollment
- Stratum A (ribociclib and gemcitabine): Between 1 and 24 years old with recurrent, progressive or refractory non-WNT, non-sonic hedgehog (SHH) (NWNS) medulloblastoma or ependymoma
- Stratum B (ribociclib and trametinib): Between 1 and 24 years old with recurrent, progressive, or refractory central nervous system (CNS) tumors, including:
- High-grade glioma
- Atypical teratoid rhabdoid tumor (ATRT)
- SHH and WNT medulloblastoma
- CNS embryonal tumors [previously called PNET])
- Stratum C (ribociclib and sonidegib): Between 10 and 39 years old with recurrent, progressive, or refractory SHH medulloblastoma and copy number loss of 9q or PTCH1 mutation. (This stratum is only open to patients with SHH medulloblastoma who are fully grown. Patients younger than 18 years old will have bone age to determine if fully grown)
Screening Phase Eligibility
Inclusion Criteria:
- Participants with recurrent, progressive, or refractory brain tumors
- At least 1 year old and younger than 25 years old at the time of screening. Exception: Participants with recurrent, progressive or refractory medulloblastoma who are at least 1 year old and younger than 40 years of age at the time of study screening are eligible for screening.
- Participants and/or guardian have the ability to understand and the willingness to sign a written informed consent document according to institutional guidelines.
Exclusion Criteria:
- Recurrent, progressive or refractory low grade glioma (LGG)
- Prior exposure to a CDK4/6 inhibitor
- History of clinically significant, uncontrolled heart disease and/or repolarization abnormalities
- History of QTc prolongation
SJMB12: A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma/PNET
Clinical and Molecular Risk-Directed Craniospinal Irradiation and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed Medulloblastoma
Diseases Treated:
Medulloblastoma (includes all variants of medulloblastoma and posterior fossa PNET)
Eligibility:
- Diagnosis of newly medulloblastoma
- At least 3 years old and younger than 22 years old (Strata W, S or N) OR
- At least 22 years old and younger than 40 years old AND has SHH medulloblastoma (Stratum S)
- Has not received previous treatment with radiation therapy or chemotherapy
- Must start treatment within 36 days of surgery to remove the tumor
SJRET6: Combination Chemotherapy in Treating Patients with Newly Diagnosed, Previously Untreated Intraocular Retinoblastoma
Protocol for the Study and Treatment of Participants with Intraocular Retinoblastoma
Diseases Treated:
Eligibility:
- Newly diagnosed retinoblastoma that has not spread beyond the eye
- Has not received previous treatment with chemotherapy or radiation therapy
- Patients who have been diagnosed with retinoblastoma in one eye who did not receive chemotherapy, but then developed retinoblastoma in the opposite eye
TINI: Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL)
Diseases Treated:
Acute lymphoblastic leukemia (ALL)
Eligibility:
- Newly diagnosed ALL
- 1 year of age or younger at the time of diagnosis
- Has not had any — or has had limited — prior therapy
- Does not have mature B-cell ALL, acute myeloid leukemia (AML) or Down syndrome
-
CSqHPV: Vaccine Therapy in Preventing Human Papillomavirus Infection in Younger Cancer Survivors
Quadrivalent Human Papillomavirus (qHPV) Vaccine in Cancer Survivors: Cross Sectional Survey and Phase II Open-Label Vaccine Trial A Consortium for Pediatric Interventional Research
Diseases Treated:
Human papillomavirus
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
Questionnaire phase
- Cancer survivor (9 to 26 years of age at study participation)
- English or Spanish-speaking
Vaccine Phase
- Survey response indicated no prior history of HPV vaccination
- Agrees to return to participating institution for 3 HPV vaccine injections
- Allergy to any component of the HPV vaccine including yeast and aluminum will not be eligible for the study
IMPAACT2002: Behavioral Therapy and Medication for Depression among Youth with HIV
Combined Cognitive Behavioral Therapy and a Medication Management Algorithm for Treatment of Depression among Youth Living with HIV in the U.S.
Diseases Treated:
Depression
Eligibility:
- 12 to 24 years old
- Receiving mental health or HIV-related care at participating IMPAACT site
- HIV-positive
- Diagnosis of nonpsychotic depression
- Current depressive symptoms that warrant intervention
- Reads and speaks English
LITE: Light Therapy to Increase Energy in Adolescents and Young Adults Newly Diagnosed with Solid Tumors: A Pilot Study
Diseases Treated:
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
- At least 12 years old
- Diagnosed with a solid tumor or lymphoma within the past 30 days
- Speaks, reads and writes in English or Spanish
- No blindness or history of eye disease including, but not limited to macular degeneration, or other diagnosed retinal problems
- Not initiated antidepressant medication, including either SSRIs in the past month, and MAOIs in the past two months
- No laser corrective eye surgery in the past 30 days
MEMCRT: Memantine to Prevent Thinking Problems in Children Receiving Radiation for Certain Brain Tumors
Memantine for Prevention of Cognitive Late Effects in Pediatric Patients Receiving Cranial Radiation Therapy for Localized Brain Tumors: A Pilot Study
Diseases Treated:
Eligibility:
- Between 6 and 21 years old
- Diagnosis of localized low-grade glioma, craniopharyngioma, ependymoma or germ cell tumor
- Initiating focal cranial radiation therapy (photon or proton)
- Able to swallow pills
- Participant and parent/legal guardian speak, read and understand English
- Normal ECG and laboratory tests
- Adequate vision and hearing
MEMREAD: Working Memory and School Readiness in Preschool-aged Children with Sickle Cell Disease: Family and Environmental Factors
Diseases Treated:
Eligibility:
This is a non-therapeutic clinical trial open to St. Jude patients only.
MPST3: Online Problem Solving Skills Training
Online Implementation of Problem-Solving Skills Training for Parents of Newly Diagnosed Childhood Cancer Patients
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
- Please see the eligibility section on the clinical trial for full inclusion and exclusion criteria.
PEESC: Evaluation of Nocturnal Enuresis and Barriers to Treatment Among Pediatric Patients with Sickle Cell Disease
Diseases Treated:
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
PNCQ: Developing a Neurocognitive Questionnaire for Childhood Cancer Survivors
Assessing Patient-Reported Neurocognitive Functioning in Pediatric Oncology: A Pilot Study Toward Developing the Pediatric Neurocognitive Questionnaire (PNCQ)
Diseases Treated:
Cancer
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients and their parents.
- 8 to 17.9 years old
- Cancer survivor who is off cancer therapy
- Parents and legal guardians of children to also enroll in the study
- Speaks English
SBANK10: Sperm Banking Among Adolescents Newly Diagnosed with Cancer: Development of a Profiling and Referral Tool
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
SEDYC: Social and Emotional Development in Children with Cancer
Diseases Treated:
Non-therapeutic
Eligibility:
This is a non-therapeutic research study open only to St. Jude patients, their parents and patients' teachers.
- Patient between 4 and 6 years old
- Primary diagnosis of brain tumor or non-CNS solid tumor
- 6 to 12 months since therapy was completed (+/- 1 month)
- Chemotherapy was part of tumor treatment
- Able to speak and read English
SJHOME: At-Home Care after Stem Cell Transplant
Health and Outpatient Management Experiences
Diseases Treated:
Non-therapeutic
Eligibility:
This is a non-therapeutic clinical trial open only to St. Jude patients.
- 12 years old or younger
- Has had a hematopoietic stem cell transplant (HCST)
- Recruitment occurs within two weeks before or after discharge from transplant admission
- Prescribed oral medication at discharge
- Speaks and reads English
SOCFUN: Social Functioning in Survivors of Pediatric Brain Tumors
Components of Social Functioning in Survivors of Pediatric Brain Tumors
Diseases Treated:
Brain tumor
Eligibility:
This study is open only to patients at St. Jude Children’s Research Hospital.
- Diagnosis of medulloblastoma or other brain tumor
- Between 8 and 12 years old
- At least 2 years after completion of therapy
- Full-time student
- Speaks English
XPD12-077: Cognitive, Academic and Psychosocial Functioning in Long-Term Survivors of Pediatric Stem Cell Transplantation
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
St. Jude patients:
- Treated with an allogeneic bone marrow or stem cell transplant at St. Jude
- 8 years of age or older
- Younger than 21 at time of transplant
- More than 5 years from date of transplant
Healthy volunteers (comparison group):
- 8 years of age or older
- Primarily speaks English
- No known history of serious illness
-
PDMCRN: Parental Decision-Making for Children with Relapsed Neuroblastoma
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
- Participant is the parent of a child with relapsed or refractory high risk neuroblastoma receiving primary oncology care or a second opinion at a participating site.
- Parent aged 18 year or older, of a child aged ≤ 18 years.
- Participating parent if the primary decision maker for the family.
- Participating parent is English-speaking.
PEPR: Patient-Reported Outcomes in Childhood Cancer Survivors
Validation of Pediatric Patient-Reported Outcomes (PEPR) for Childhood Cancer Survivors
Diseases Treated:
Cancer
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients and their parents.
- St. Jude childhood cancer survivors between 8 and 17 years old
- Parents of St. Jude childhood cancer survivors
PNCQ: Developing a Neurocognitive Questionnaire for Childhood Cancer Survivors
Assessing Patient-Reported Neurocognitive Functioning in Pediatric Oncology: A Pilot Study Toward Developing the Pediatric Neurocognitive Questionnaire (PNCQ)
Diseases Treated:
Cancer
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients and their parents.
- 8 to 17.9 years old
- Cancer survivor who is off cancer therapy
- Parents and legal guardians of children to also enroll in the study
- Speaks English
PRO-CTCAE: Creating and Validating Child Adverse Event Reporting in Oncology Trials: Pediatric PRO-CTCAE Project
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
U-CHAT: Understanding Communication in Health Care to Achieve Trust
Understanding Communication in Health Care to Achieve Trust: A Prospective Longitudinal Investigation of Communication between Pediatric Oncologists, Children/Adolescents with High-Risk Cancer, and their Families at the Stressful Times of Disease Relapse or Progression
Diseases Treated:
Non-therapeutic
Eligibility:
Primary oncologist:
- Attending physician age 18 years or older who provides medical care to patients in the Solid Tumor Clinic at St. Jude Children’s Research Hospital
- Primary hematology-oncology fellows age 18 or older (audio-recorded disease reevaluation only)
Parents of children with cancer:
- Age 18 or older
- Biological parent, step-parent or primary legal guardian
- Reads and speaks English
Patients:
- Primary oncologist is enrolled in the study.
- 30 years old or younger
- Diagnosed with one or more of the following diseases:
- High-risk neuroblastoma
- Any sarcoma
- Any carcinoma
- Desmoplastic small round cell tumor
- Incompletely resected or metastatic retinoblastoma, Wilms tumor, germ cell tumor, hepatoblastoma or melanoma
- Disease has relapsed, progressed or not responded to therapy
-
DWSARC: Diffusion Weighted Magnetic Resonance Imaging In Pediatric Sarcomas
Diseases Treated:
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
- Participant is under the care of a St. Jude physician with a known or suspected, newly diagnosed bone or soft tissue sarcoma who will be treated on or as per disease specific protocols and has not begun therapy OR participant has started therapy and the needed research imaging can be performed within 2-5 days of starting treatment.
- Participant has undergone or is scheduled for PET-CT, Bone Scan, or PET-CT and Bone Scan within two (2) weeks of the whole body and primary tumor DWI-MRI.
- Participant meets institutional MRI safety screening requirements.
- Participant has not undergone primary tumor resection prior to arrival to St. Jude.
RERTEP: Surgery and Second-Course Radiation Therapy in Treating Younger Patients With Recurrent Ependymoma
A Phase II Trial of Surgery and Fractionated Re-irradiation for Recurrent Ependymoma
Diseases Treated:
Recurrent ependymoma
Eligibility:
- Progressive intracranial ependymoma after prior focal irradiation
- At least 1 year old and younger than 21 years old
- Adequate performance status (ECOG less than 3)
- Does not require mechanical ventilation
- Interval from start of initial radiation therapy to enrollment greater than 9 months
RMS13: Chemotherapy, Surgery and Proton Beam Radiation Therapy in Treating Patients with Newly Diagnosed Rhabdomyosarcoma
Risk-Adapted Focal Proton Beam Radiation and/or Surgery in Participants with Low-, Intermediate- and High-Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy
Diseases Treated:
Rhabdomyosarcoma (low-risk, intermediate-risk and high-risk)
Eligibility:
- Newly diagnosed rhabdomyosarcoma
- Younger than 22 years (eligible until 22nd birthday)
- No previous treatment with chemotherapy or radiation therapy
RT2CR: Limited Surgery and Proton Beam Radiation Therapy in Treating Younger Patients with Brain Tumors
A Phase II Trial of Limited Surgery and Proton Therapy for Craniopharyngioma and Observation for Craniopharyngioma after Radical Resection
Diseases Treated:
Eligibility:
- 21 years of age or younger
- Diagnosis of craniopharyngioma
- Has not been previously treated with radiation therapy
RT3CR: Proton Therapy for Pediatric Craniopharyngioma
A Phase II Trial of Intensity-Modulated Proton Therapy for Incompletely Resected Craniopharyngioma and Observation for Craniopharyngioma After Radical Resection
Diseases Treated:
Eligibility:
- 21 years old or younger
- Diagnosis of craniopharyngioma
SBRT1: Stereotactic Radiation Therapy for Pediatric Sarcomas
A Phase II Study of Hypofractionated Stereotactic Radiotherapy in the Treatment of Metastatic Pediatric Sarcomas of Bony Sites
Diseases Treated:
Eligibility:
- Participant has histologically or cytologically confirmed diagnosis:
- Nonrhabdomyosarcoma of soft tissue
- Ewing sarcoma
- Osteosarcoma at any site
- Participant must be greater than 3 years of age and < 40 years of age.
- Participant has not had any prior radiotherapy to the treatment site.
-
EPSTRV: Retroviral Vector Mediated Globin Gene Transfer to Correct Sickle Cell Anemia or Thalassemia
Experimental Evaluation of the Potential to Correct the Pathophysiology of Sickle Cell Anemia or Thalassemia by Retroviral Vector Mediated Globin Gene Transfer
Diseases Treated:
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
- Participant’s age is equal to or greater than two (2) years old
- No active sickle cell disease
- Adequate blood counts
INSIGHT-HD: Investigating the Genetics of Hematologic Diseases
Diseases Treated:
Non-malignant blood diseases (non-therapeutic)
Eligibility:
- Receiving therapy or a consultation for a non-malignant blood disorder
- Biological relatives (with or without a non-malignant blood disorder) who agree to undergo genetic testing
MEMREAD: Working Memory and School Readiness in Preschool-aged Children with Sickle Cell Disease: Family and Environmental Factors
Diseases Treated:
Eligibility:
This is a non-therapeutic clinical trial open to St. Jude patients only.
NOTCHES1: Novel Therapies in Children with Sickle Cell Disease
A Phase IIa, Open-label, Single and Multiple Dose Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Exploratory Treatment Effect of GBT440 in Adolescents with Sickle Cell Disease
Diseases Treated:
Eligibility:
- 12 to 17 years old
- Diagnosis of sickle cell disease
- Able to swallow capsules
PMVOC: Pain Management of Vaso-Occlusive Crisis in Children and Young Adults with Sickle Cell Disease
Diseases Treated:
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
REHASH: Barriers to Hydroxyurea Adherence for Sickle Cell Disease
Re-Aiming at Hydroxyurea Adherence for Sickle Cell with MHealth
Diseases Treated:
Eligibility:
This study is limited to patients living in the Memphis, Tennessee region.
Phase I
- Diagnosis of sickle cell disease
- Between 15 and 44.9 years old
- Speaks English
Phase II
- Diagnosis of sickle cell disease
- Between 15 and 44.9 years old
- Receiving hydroxyurea treatment for sickle cell disease
- Owns a smart phone
- Not currently receiving text messages for improving hydroxyurea adherence
- Not currently undergoing hydroxyurea dose escalation
- Not on any investigational new drug intervention study for sickle cell disease
SCCRIP: Sickle Cell Research and Intervention Program
Diseases Treated:
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.- Participant has a diagnosis of Sickle Cell Disease of any genotype.
TADO: A Study of Prasugrel in Pediatric Participants With Sickle Cell Disease (SCD)
A Phase 3 Double-Blind, Randomized, Efficacy and Safety Comparison of Prasugrel and Placebo in Pediatric Patients with Sickle Cell Disease
Diseases Treated:
Eligibility:
- Participant with Sickle Cell Disease (laboratory determined HbSS or HbS beta zero thalassemia) who have had >2 episodes of Vaso-occlusive crisis in the past year.
- Participants >2 years of age and < 18 years of age.
-
Featured Trial
OSTPDL1: A Phase II Trial of Avelumab for Patients with Recurrent or Progressive Osteosarcoma
Diseases Treated:
Eligibility:
- At least 12 years old and younger than 25 years old
- Osteosarcoma that has relapsed, progressed or become refractory to conventional therapy
A031102: Standard-Dose Combination Chemotherapy Compared to High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients with Relapsed or Refractory Germ Cell Tumors
A Randomized Phase III Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) with High-Dose Chemotherapy Using Mobilizing Paclitaxel Plus Ifosfamide followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell Tumors
Diseases Treated:
Eligibility:
- 14 years old or older
- Diagnosis of germ cell tumor (GCT)
- Previously received 3 to 6 cycles of cisplatin-based chemotherapy
- No more than one prior line of chemotherapy
- No prior treatment with high-dose chemotherapy
ADV1312: WEE1 Inhibitor MK-1775 and Irinotecan Hydrochloride in Treating Younger Patients With Relapsed or Refractory Solid Tumors
A Phase I/II Study of MK-1775 (AZD1775, IND# 121422) in Combination with Oral Irinotecan In Children, Adolescents, and Young Adults with Relapsed or Refractory Solid Tumors
Diseases Treated:
Relapsed or refractory solid tumors
Eligibility:
- Participant is >12 months and < 21 years of age at the time of study entry.
- Participant has had histologic verification of malignancy at original diagnosis or relapse.
- Participant has serum tumor markers including alpha-fetoprotein or beta-HCG.
- Participant has a relapsed or refractory solid tumor.
ADV1414: Phase I Study of Selinexor to Treat Patients with Recurrent and Refractory Pediatric Solid Tumors
A Phase I Study of Selinexor (KPT-330, IND #125052), a Selective XPO1 Inhibitor, in Recurrent and Refractory Pediatric Solid Tumors, Including CNS Tumors
Diseases Treated:
Eligibility:
- Diagnosis of solid tumor that is resistant to other anticancer therapy or has come back after therapy. Includes lymphoma and central nervous system (CNS) tumors that may or may not require surgery.
- Fully recovered from the acute toxic effects of all prior anticancer therapy
- At least 1 but not more than 21 years of age
- Able to swallow tablets whole
ADV1416: A Study of Ramucirumab in Children with Solid Tumors and Brain Tumors
A Phase I Study of Ramucirumab, a Human Monoclonal Antibody Against the Vascular Endothelial Growth Factor-2 (VEGFR-2) Receptor in Children with Refractory Solid Tumors, Including CNS Tumors
Diseases Treated:
Eligibility:
- 12 months old or older and younger than 21 years old
- Diagnosis:
- Part A - Non-central nervous system (CNS) tumor that returned after treatment or did not respond to treatment
- Part B – CNS tumor that returned after treatment or did not respond to treatment
- No other proven therapy options
ADVL1513: Entinostat for Children with Recurrent or Refractory Solid Tumors
A Phase I Study of Entinostat, an Oral Histone Deacetylase Inhibitor, in Pediatric Patients with Recurrent or Refractory Solid Tumors, including CNS Tumors and Lymphoma
Diseases Treated:
Solid Tumor, CNS Tumor, Lymphoma
Eligibility:
- 12 months to 21 years old
- Able to swallow whole tablets
- Diagnosis of recurrent or refractory solid tumor, including CNS tumor and lymphoma
ADVL1515: Prexasertib for Children with Recurrent or Refractory Solid Tumors
A Phase I Study of LY2606368 (prexasertib mesylate monohydrate), A CHK1/2 Inhibitor, in Pediatric Patients with Recurrent or Refractory Solid Tumors, including CNS Tumors
Diseases Treated:
Solid Tumor, CNS Tumor
Eligibility:
- 12 months to 21 years old
- Diagnosis of recurrent or refractory solid tumor, including CNS tumor
ANBLB1: Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma
Neuroblastoma Biology Studies
Diseases Treated:
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
- All newly diagnosed suspected:
- neuroblastoma,
- ganglioneuroblastoma, or
- ganglioneuroma (maturing subtype) patients
- Less than or equal to 21 years of age
- Seen at Children's Oncology Group (COG) institutions
AOST1421: Combination Drug Therapy to Treat Patients with Recurrent Osteosarcoma
A Phase II Study of Human-Mouse Chimeric Anti-Disialoganglioside Monoclonal Antibody ch14.18 (Dinutuximab) in Combination with Sargramostim (GM-CSF) in Patients with Recurrent Osteosarcoma
Diseases Treated:
Eligibility:
- Younger than 30 years old
- Original diagnosis of osteosarcoma
- Osteosarcoma has come back in the lungs after original treatment
- Lung tumors have been removed surgically within the last 4 weeks before enrolling in the study
BMNIRN: Talazoparib Plus Irinotecan With or Without Temozolomide in Children with Refractory or Recurrent Solid Malignancies
A Phase I Study of Talazoparib (BMN 673) Plus Irinotecan With or Without Temozolomide in Children with Refractory or Recurrent Solid Malignancies
Diseases Treated:
Relapsed or refractory solid tumors
Eligibility:
- Participant has refractory or recurrent solid tumor for which there is no standard therapy.
- Participant has had histologic verification of malignancy at original diagnosis or at the time of relapse.
- Participant is twelve (12) months to twenty-five (25) years of age at the time of enrollment on study.
- Participant life expectancy is at least eight (8) weeks.
BRF116: A Study to Determine Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib In Children and Adolescent Subjects
Phase I/IIa, 2-Part, Multi-Center, Single-Arm, Open-Label Study to Determine the Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib in Children and Adolescent Subjects with Advance BRAF V600-Mutation Positive Solid Tumors
Diseases Treated:
Solid tumors, giomas, hystiocytosis
Eligibility:
- Participant is greater or equal to 12 months and less than 18 years at the time of signing the informed consent form.
- Participant has BRAF V600 mutation positive tumor as confirmed in a CLIA-approved laboratory or equivalent
- Participant has recurrent disease, refractory disease, or progressive disease after having received at least one standard therapy for their disease, OR participant has metastatic (or surgically unresectable) melanoma, and is being enrolled for first-line treatment. Melanoma participants with CNS involvement may be enrolled.
DWSARC: Diffusion Weighted Magnetic Resonance Imaging In Pediatric Sarcomas
Diseases Treated:
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
- Participant is under the care of a St. Jude physician with a known or suspected, newly diagnosed bone or soft tissue sarcoma who will be treated on or as per disease specific protocols and has not begun therapy OR participant has started therapy and the needed research imaging can be performed within 2-5 days of starting treatment.
- Participant has undergone or is scheduled for PET-CT, Bone Scan, or PET-CT and Bone Scan within two (2) weeks of the whole body and primary tumor DWI-MRI.
- Participant meets institutional MRI safety screening requirements.
- Participant has not undergone primary tumor resection prior to arrival to St. Jude.
EWS1221: Phase III Study of Ganitumab with Chemotherapy for Patients with Metastatic Ewing Sarcoma
Randomized Phase III Trial Evaluating the Addition of the IGF-1R Monoclonal Antibody Ganitumab (AMG 479, NSC# 750008, IND# 120449) to Multiagent Chemotherapy for Patients with Newly Diagnosed Metastatic Ewing Sarcoma
Diseases Treated:
Eligibility:
- Younger than or equal to 50 years old
- Diagnosis of Ewing sarcoma or peripheral primitive neuroectodermal tumor (PNET) arising from bone or soft tissue and with metastatic disease involving lung, bone, bone marrow or other metastatic site
EZH102: Tazemetostat in Children and Young Adults with Synovial Sarcoma or INI1-Negative Tumors
A Phase I Study of the EZH2 Inhibitor Tazemetostat in Pediatric Subjects with Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma
Diseases Treated:
- Rhabdoid tumor
- Synovial sarcoma
- INI 1-negative tumor
Eligibility:
- Between 6 months and 21 years old
- Relapsed or refractory rhabdoid tumors, INI1-negative tumors or synovial sarcoma
IPACTR: International Pediatric Adrenocortical Tumor Registry
Diseases Treated:
Adrenocortical tumors (carcinoma and adenoma)
Eligibility:
- Diagnosis of an adrenocortical tumor (ACT)
- 21 years of age or younger at diagnosis
- Relatives of patients with ACT
iRET: Intravitreal Chemotherapy for Children with Retinoblastoma
Intravitreal Carboplatin for the Treatment of Participants with Recurrent or Refractory Intraocular Reintoblastoma
Diseases Treated:
Eligibility:
- Age 17 or younger
- Diagnosis of retinoblastoma that did not go away with treatment or came back after treatment
LILOLA: A Study of Olaratumab Alone and in Combination with Standard Chemotherapies in Children with Cancer
A Study of Olaratumab Alone and in Combination with Standard Chemotherapies in Children with Cancer
Diseases Treated:
Cancer
Eligibility:
- Younger than 18 years old
- Diagnosis of solid tumor that has not responded to treatment or came back after treatment (excluding melanoma and lymphomas)
LITE: Light Therapy to Increase Energy in Adolescents and Young Adults Newly Diagnosed with Solid Tumors: A Pilot Study
Diseases Treated:
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
- At least 12 years old
- Diagnosed with a solid tumor or lymphoma within the past 30 days
- Speaks, reads and writes in English or Spanish
- No blindness or history of eye disease including, but not limited to macular degeneration, or other diagnosed retinal problems
- Not initiated antidepressant medication, including either SSRIs in the past month, and MAOIs in the past two months
- No laser corrective eye surgery in the past 30 days
LOXO-TRK: Testing Larotrectinib (LOXO-101) in Children with Advanced Solid Tumors or Brain Tumors
A Phase 1/2 Study of the Oral TRK Inhibitor LOXO-101 in Pediatric Patients with Advanced Solid or Primary Central Nervous System Tumors (LOXO-TRK-15003)
Diseases Treated:
Solid Tumors, Central Nervous System Tumors
Eligibility:
Phase 1
- Birth through 21 years of age with locally advanced or metastatic solid tumor or primary CNS tumor that has progressed or was nonresponsive to therapy and for which there is no standard or available curative therapy, OR
- Infants from birth and older with diagnosis of malignancy and with documented NTRK fusion that has progressed or was nonresponsive to therapy and for which there is no standard or available curative therapy, OR
- Patients with locally advanced infantile fibrosarcoma who would require disfiguring surgery or limb amputation to achieve complete surgical resection
Phase 2
- Infants from birth and older at C1D1 with locally advanced or metastatic infantile fibrosarcoma OR
- Birth through 21 years old at C1D1 with locally advanced or metastatic solid tumor or primary CNS tumor that has relapsed, progressed or was not responsive to therapy and for which no standard or available curative therapy with a NTRK gene funsion OR
- More than 21 years old with tumor diagnosis typical of a pediatric patient and an NTRK fusion
MACMEL: A Study to Analyze Melanoma Lesions in Children and Teens
Molecular Analysis of Childhood and Adolescent Melanocytic Lesions
Diseases Treated:
Eligibility:
- Diagnosed with a melanoma tumor that is malignant (cancerous) or that might be cancerous, including:
- Conventional or “adult-type” melanoma
- Spitzoid melanoma/atypical Spitz tumor
- Congenital melanoma
- Melanoma arising in a giant congenital nevus
- Melanocytic lesions with indeterminate biological behavior (e.g., pigment-synthesizing melanomas)
- Younger than 19 years of age
MARB: Molecular Analysis of Retinoblastoma
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
MEK116: Study to Investigate Safety, Pharmacokinetic (PK), Pharmacodynamic (PD) and Clinical Activity of Trametinib in Subjects With Cancer or Plexiform Neurofibromas and Trametinib in Combination With Dabrafenib in Subjects With Cancers Harboring V600 Mutations
An Open- Label, Dose Escalation, Phase I/II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the MEK Inhibitor Trametinib in Children and Adolescent Subjects with Cancer or Plexiform Neurofibromas and Trametinib in Combination with Dabrafenib in Children and Adolescents with Cancers Harboring V600 Mutations.
Diseases Treated:
Relapsed or refractory solid tumor
Eligibility:
- Participant is at least one month old and younger than 18 years old at the time of signing the informed consent (in Part A, participants < 2 years of age are not included).
- Participant has a histologically confirmed solid tumor
- Participant has a disease that is relapsed or refractory to all potentially curative standard treatment regimens, or has a disease for which there is no standard treatment regimen that is potentially curative.
MEKPEM: A Phase I/II Study of Pembrolizumab (MK-3475) in Children with Advanced Melanoma or a PD-L1 Positive Advanced Relapsed or Refractory Solid Tumor or Lymphoma
(Merck study KEYNOTE-051, IND# 110,080, dated 10-15/2014). EudraCT NUMBER: 2014-002950-38
Diseases Treated:
Advanced melanoma or PD-L1 positive advanced relapsed or refractory solid tumor or lymphoma
Eligibility:
- Participant has advanced melanoma or PD-L1 positive advanced, relapsed or refractory solid tumor or lymphoma
- Participant of child bearing potential has a negative pregnancy test 72 hours prior to medication administration
- Participant has appropriate liver and kidney function
NB2012: Therapy for Children with Advanced Stage High-Risk Neuroblastoma
Anti-GD2 Monoclonal Antibody Hu14.18K322A and Combination Chemotherapy before Autologous Stem Cell Transplant and Radiation Therapy in Treating Younger Patients with Previously Untreated High-Risk Neuroblastoma
Diseases Treated:
Eligibility:
- Younger than 19 years old
- Newly diagnosed, advanced stage, high-risk neuroblastoma
- Histologic proof of neuroblastoma or positive bone marrow for tumor cells with increased urine catecholamine
- Adequate kidney and liver functions
NBL1232: Response and Biology-Based Risk Factor-Guided Therapy in Treating Younger Patients With Non-High Risk Neuroblastoma
Utilizing Response- and Biology-Based Risk Factors to Guide Therapy in Patients with Non-High-Risk Neuroblastoma (ANBL1232)
Diseases Treated:
Neuroblastoma, ganglioneuroblastoma
Eligibility:
- Participant has been enrolled on ANBLB1 (ANBL00B1).
- Participant has newly diagnosed MYCN non-amplified neuroblastoma or MYCN non-amplified ganglioneuroblastoma.
- Participant is less than 12 months (Group A) and less than 18 months (Group B and Group C) of age at diagnosis.
OSTPDL1: A Phase II Trial of Avelumab for Patients with Recurrent or Progressive Osteosarcoma
A Phase II Trial of Avelumab, a Fully Humanized Antibody that Targets Cells Expressing PD-L1 in Patients with Recurrent or Progressive Osteosarcoma
Diseases Treated:
Eligibility:
- At least 12 years old and younger than 25 years old
- Osteosarcoma that has relapsed, progressed or become refractory to conventional therapy
PBTC45: MK-3475 in Treating Children with Recurrent, Progressive or Refractory HGGs, DIPGs and Hypermutated Brain Tumors
A Safety and Preliminary Efficacy Trial of MK-3475 (Pembrolizumab; anti PD-1) in Children with Recurrent, Progressive or Refractory High-Grade Gliomas (HGG), DIPGs and Hypermutated Brain Tumors
Diseases Treated:
Recurrent, progressive, or refractory high-grade gliomas
Eligibility:
- Participant has recurrent, progressive or refractory non-brainstem high-grade glioma or diffuse intrinsic pontine glioma (DIPG)
- Participant is 1 to 18 years of age
- Participant has bi-measurable disease on MRI
- Participant has received prior radiation therapy and/or chemotherapy and has not received myelosuppressive anticancer chemotherapy for at least three (3) weeks
PDMCRN: Parental Decision-Making for Children with Relapsed Neuroblastoma
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
- Participant is the parent of a child with relapsed or refractory high risk neuroblastoma receiving primary oncology care or a second opinion at a participating site.
- Parent aged 18 year or older, of a child aged ≤ 18 years.
- Participating parent if the primary decision maker for the family.
- Participating parent is English-speaking.
RBAPP: Smartphone App for Retinoblastoma
Determination of the Sensitivity and Specificity of a Smartphone Application to Detect Retinoblastoma
Diseases Treated:
Eligibility:
- 7 years old or younger
- Part I
- Diagnosed with retinoblastoma and has not received any treatment OR
- Diagnosed with cataracts and has not received any treatment OR
- Diagnosed with glaucoma and has not received any treatment
- Part II
- Referred to an eye doctor to check for leukocoria or other eye conditions
- Part III
- Diagnosed with retinoblastoma and is receiving treatment
REFGCT: A Phase II Study of Two Drugs for Relapsed or Refractory Malignant Germ Cell Tumors
A Phase II Study of Sirolimus and Erlotinib in Recurrent and Refractory Germ Cell Tumors
Diseases Treated:
Refractory and recurrent solid tumors
Eligibility:
- Participant is between 1-25 years old e at the time of enrollment (Note: eligibility up to age 50 years for other participating sites).
- Participant has had histologic verification of an extracranial germ cell tumor that is not a pure teratoma (mature or immature), pure germinoma, or pure seminoma.
- Participant has relapsed or refractory disease following at least two prior platinum-containing chemotherapy regimens.
- Patients must have measurable disease, documented according to RECIST criteria, or evaluable disease with a standard tumor marker (AFP and/or HCG) greater than 10 times the upper limit of normal.
- Other requirements for this study.
RETCELL: A Study of Children with Heritable Retinoblastoma
Feasibility, Validation and Differentiation of Induced Pluripotent Stem Cells Produced from Patients with Heritable Retinoblastoma
Diseases Treated:
Retinoblastoma (non-therapeutic)
Eligibility:
Family history of retinoblastoma with one of the following:
- RB1 mutation OR
- Diagnosis of bilateral retinoblastoma OR
- Diagnosis of unilateral retinoblastoma with RB1 mutation or MYCN amplification
RMS13: Chemotherapy, Surgery and Proton Beam Radiation Therapy in Treating Patients with Newly Diagnosed Rhabdomyosarcoma
Risk-Adapted Focal Proton Beam Radiation and/or Surgery in Participants with Low-, Intermediate- and High-Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy
Diseases Treated:
Rhabdomyosarcoma (low-risk, intermediate-risk and high-risk)
Eligibility:
- Newly diagnosed rhabdomyosarcoma
- Younger than 22 years (eligible until 22nd birthday)
- No previous treatment with chemotherapy or radiation therapy
RST1321: Radiation Therapy With or Without Combination Chemotherapy or Pazopanib Hydrochloride Before Surgery in Treating Patients With Newly Diagnosed Non-Rhabdomyosarcoma Soft Tissue Sarcomas That Can be Removed by Surgery
Pazopanib Neoadjuvant Trial In Non-Rhabdomyosarcoma Soft Tissue Sarcomas (PAZNTIS): A Phase II/III Randomized Trial of Preoperative Chemoradiation or Preoperative Radiation Plus or Minus Pazopanib (NSC# 737754, IND# 118613) (ARST1321)
Diseases Treated:
Non-rhabdomyosarcoma soft tissue sarcoma
Eligibility:
- > 2 years at the time of the biopsy that established the diagnosis of NRSTS.
- Participant has a NRSTS in the extremity or trunk.
- Participant has adequate bone marrow function.
- Participant has not had prior Anthracycline or Ifosfamide therapy.
- Participant is not HIV-positive.
SBRT1: Stereotactic Radiation Therapy for Pediatric Sarcomas
A Phase II Study of Hypofractionated Stereotactic Radiotherapy in the Treatment of Metastatic Pediatric Sarcomas of Bony Sites
Diseases Treated:
Eligibility:
- Participant has histologically or cytologically confirmed diagnosis:
- Nonrhabdomyosarcoma of soft tissue
- Ewing sarcoma
- Osteosarcoma at any site
- Participant must be greater than 3 years of age and < 40 years of age.
- Participant has not had any prior radiotherapy to the treatment site.
SJATRT: Phase II Study of Alisertib Therapy for Rhabdoid Tumors
Phase II Study of Alisertib as a Single Agent in Recurrent or Progressive Central Nervous System (CNS) Atypical Teratoid Rhabdoid Tumors (ATRT) and Extra-CNS Malignant Rhabdoid Tumors (MRT) and in Combination Therapy in Newly Diagnosed ATRT
Diseases Treated:
Brain Tumor : Recurrent, progressive, or newly diagnosed atypical teratoid rhabdoid brain tumors (ATRT)
Solid Tumor : Progressive extra-CNS malignant rhabdoid solid tumors (MRT)Eligibility:
- Has one of these types of tumors:
- Newly diagnosed atypical teratoid rhabdoid tumors (ATRTs) or synchronous extraneural ATRTs
- ATRTs or malignant rhabdoid tumors (MRTs) that have come back after previous treatment (recurrent disease)
- ATRTs or MRTs that are growing after previous treatment (progressive disease)
- 21 years of age or younger
SJRET6: Combination Chemotherapy in Treating Patients with Newly Diagnosed, Previously Untreated Intraocular Retinoblastoma
Protocol for the Study and Treatment of Participants with Intraocular Retinoblastoma
Diseases Treated:
Eligibility:
- Newly diagnosed retinoblastoma that has not spread beyond the eye
- Has not received previous treatment with chemotherapy or radiation therapy
- Patients who have been diagnosed with retinoblastoma in one eye who did not receive chemotherapy, but then developed retinoblastoma in the opposite eye
U-CHAT: Understanding Communication in Health Care to Achieve Trust
Understanding Communication in Health Care to Achieve Trust: A Prospective Longitudinal Investigation of Communication between Pediatric Oncologists, Children/Adolescents with High-Risk Cancer, and their Families at the Stressful Times of Disease Relapse or Progression
Diseases Treated:
Non-therapeutic
Eligibility:
Primary oncologist:
- Attending physician age 18 years or older who provides medical care to patients in the Solid Tumor Clinic at St. Jude Children’s Research Hospital
- Primary hematology-oncology fellows age 18 or older (audio-recorded disease reevaluation only)
Parents of children with cancer:
- Age 18 or older
- Biological parent, step-parent or primary legal guardian
- Reads and speaks English
Patients:
- Primary oncologist is enrolled in the study.
- 30 years old or younger
- Diagnosed with one or more of the following diseases:
- High-risk neuroblastoma
- Any sarcoma
- Any carcinoma
- Desmoplastic small round cell tumor
- Incompletely resected or metastatic retinoblastoma, Wilms tumor, germ cell tumor, hepatoblastoma or melanoma
- Disease has relapsed, progressed or not responded to therapy
-
ANBLB1: Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma
Neuroblastoma Biology Studies
Diseases Treated:
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
- All newly diagnosed suspected:
- neuroblastoma,
- ganglioneuroblastoma, or
- ganglioneuroma (maturing subtype) patients
- Less than or equal to 21 years of age
- Seen at Children's Oncology Group (COG) institutions
IPACTR: International Pediatric Adrenocortical Tumor Registry
Diseases Treated:
Adrenocortical tumors (carcinoma and adenoma)
Eligibility:
- Diagnosis of an adrenocortical tumor (ACT)
- 21 years of age or younger at diagnosis
- Relatives of patients with ACT
MARB: Molecular Analysis of Retinoblastoma
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
SBANK10: Sperm Banking Among Adolescents Newly Diagnosed with Cancer: Development of a Profiling and Referral Tool
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
TBANK: Protocol for Collecting, Banking, and Distributing Human Tissue Samples: St. Jude Children’s Research Hospital Biorepository
Eligibility:
This is a non-therapeutic clinical trial that is only open to St. Jude patients.
- All newly diagnosed suspected:
-
FLUTRAN: Flu Vaccine Dose Comparison in Children Who Have Had Stem Cell Transplants
Comparison of High vs. Standard Dose Flu Vaccine in Pediatric Stem Cell Transplant Recipients
Diseases Treated:
Influenza
Eligibility:
- At least 3 years old and younger than 17
- Allogeneic hematopoietic stem cell transplant recipient
- At least 3 and not more than 35 months after transplant
- Platelet count of at least 30,000
FLUVIT: A Double-Blind Randomized, Placebo Controlled Study of Antibody Induction By Vitamin Supplementation At The Time Of Influenza Virus Vaccination In Children
Eligibility:
- Participant is age two (2) to eight (8) years inclusive at the time of enrollment.
- Participant is not currently using investigational or immunosuppressive drugs (e.g. steroids) at the time of enrollment.
- Participant is not currently taking a daily (routine) Vitamin A, D or multi-vitamin. Note: Participant who report occasional or sporadic vitamin use will be allowed to enroll.
SENDAI: A Phase I Study of Unmodified Live Intranasal Sendai Virus Vaccine in Children and Toddlers: Assessment of Safety and Immunogenicity
Eligibility:
- Child is greater than or equal to twelve (12) months and less than twenty-four (24) months.
- Child has adequate blood, liver and kidney function.
- Child has no history of lung disease, asthma, and hospitalization for respiratory illness, immunodeficiency, sickle cell disease, or any other serious underlying condition.