St. Jude Clinical Trials
ED0157: Phase 1 Pediatric PK/PD Study
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.
FLOPET: PET Scan Studies to Analyze Neuroblastoma and Pheochromocytoma Tumors
Diseases Treated:
Neuroblastoma, pheochromocytoma
Eligibility:
This study is open to St. Jude patients only.
- Known or suspected neuroblastoma or pheochromocytoma
- At least 1 year old
HALGG: Hippocampal-Avoidance Using Proton Therapy in Children with Brain Tumors
Diseases Treated:
Eligibility:
- At least 6 years old and younger than 22
- Diagnosis of low-grade glioma
INOMRD: Inotuzumab Ozogamicin for Children with High-Risk B-Cell ALL
Diseases Treated:
Eligibility:
- Younger than 22 years old
- Diagnosis of B-cell acute lymphoblastic leukemia (B-ALL) with minimal residual disease (MRD) between 0.1 and 4.99% after prior chemotherapy, relapse or stem cell transplant
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
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, meningioma 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
PMVOCVR: Virtual Reality Therapy for Vaso-Occlusive Crisis in Patients with Sickle Cell Disease
Diseases Treated:
Eligibility:
This is a non-therapeutic clinical trial that is open only to patients at St. Jude or Methodist Healthcare.
- Between 6 and 25 years old
- Diagnosed with sickle cell disease
- Seeking care for acute vaso-occlusive crisis pain at St. Jude Children’s Research Hospital or Methodist Healthcare
- Speaks English
REF2HCT: Haploidentical Bone Marrow Transplant for Leukemia and Lymphoma
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
RT3CR: Proton Therapy for Pediatric Craniopharyngioma
Diseases Treated:
Eligibility:
- 21 years old or younger
- Diagnosis of craniopharyngioma
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
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, high-grade glioma (HGG), CNS embryonal tumors, and atypical teratoid rhabdoid tumor (ATRT)
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
SJELIOT: Phase I Study of a CHK1/2 Inhibitor Therapy in Combination with Chemotherapy for Children and Adolescents with Refractory or Recurrent Medulloblastoma Brain Tumors
Diseases Treated:
Eligibility:
Eligibility Overview
- Recurrent, refractory or progressive medulloblastoma
- At least 1 year old and younger than 25 years old
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
SJRET6: Combination Chemotherapy in Treating Patients with Newly Diagnosed, Previously Untreated 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
Collaborative Clinical Trials
ACNS1721: A Study of the Drug Veliparib with Radiation Therapy in Patients with Newly Diagnosed High-Grade Glioma
Diseases Treated:
Eligibility:
- 3 to 25 years old
- Newly diagnosed high-grade-glioma[SJ1] , such as anaplastic astrocytoma or glioblastoma
- Negative test for H3 K27M mutation
- Negative test for BRAFV600 mutation
ADV1414: Phase I Study of Selinexor to Treat Patients with Recurrent and Refractory Pediatric Solid 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
ADVL1823: Larotrectinib (LOXO-101) in Children with TRK Fusion Solid Tumors and Relapsed Leukemia
Diseases Treated:
Eligibility:
- 21 years old or younger (at St. Jude)
- Newly diagnosed infantile fibrosarcoma or solid tumor with NTRK1, NTRK2 or NTRK3 fusion OR
- Relapsed/refractory acute leukemia with NTRK1, NTRK2 or NTRK3 fusion
CASPER: A Study to Evaluate the Safety and Efficacy of CRISPR Cas9 Gene Editing in Patients with Severe Sickle Cell Disease
Diseases Treated:
Eligibility:
- 18 to 35 years old (Ages 18 to 25 at St. Jude)
- Diagnosis of severe sickle cell disease (SCD)
LOXORET: Phase I/II Study of LOXO-292 (Selpercatinib) in Patients with Advanced RET-Altered Solid Tumors or Brain Tumors
Diseases Treated:
Solid tumors, Brain tumors
Eligibility:
- 6 months to 21 years old
- Solid tumor or brain tumor that has progressed or spread
- Failed standard treatment
- RET gene alteration
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
MEKPEM: A Phase I/II trial of MK-3475 (pembrolizumab) in children’s solid tumors and lymphomas
Diseases Treated:
Advanced melanoma or PD-L1 positive advanced relapsed or refractory solid tumor or lymphoma or high-grade glioma
Eligibility:
- Between 6 months and 18 years old with diagnosis of MSI-H solid tumor OR
- Between 12 years and 18 years old with diagnosis of melanoma OR
- Between 3 and 18 years old with relapsed or refractory classical Hodgkin lymphoma
- Negative pregnancy test 72 hours prior to medication administration in participants of child-bearing potential
- Appropriate liver and kidney functions
P1093: Safety of and Immune Response to Dolutegravir 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.)
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
PBTC49: Study of Savolitinib in Recurrent, Progressive or Refractory Medulloblastoma, HGG or DIPG
Diseases Treated:
Diffuse intrinsic pontine glioma (DIPG)
Eligibility:
- Recurrent, refractory or progressive medulloblastoma, high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG)
- Evidence of genetic activation of the MET pathway (expansion co-hort)
- At least 5 years old and 21 years old or younger
PEPN1812 : Study of Flotetuzumab in Children with Relapsed or Refractory Acute Myeloid Leukemia
Diseases Treated:
Eligibility:
- Younger than 21 years of age
- Diagnosed with recurrent or refractory acute myeloid leukemia (AML)
- Weigh more than 17kg
- Fully recovered from the acute toxic effects of all prior anti-cancer therapy
PNOC013: Study of REGN2810 Immunotherapy in Children with Relapsed or Refractory Solid or CNS Tumors and Study of REGN2810 combined with radiation in Children with Newly Diagnosed or Recurrent Glioma
Diseases Treated:
Diffuse Intrinsic Pontine Glioma, Glioma, CNS Tumor, Solid Tumor
Eligibility:
- Diagnosed with one of the following:
- Recurrent or refractory solid tumor or central nervous system (CNS) tumor
- Diffuse Intrinsic Pontine Glioma (DIPG)
- Newly diagnosed or recurrent high-grade glioma
- Younger than 18 years old (Phase I) or between 3 and 25 years old (Efficacy Phase)
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.
STARTRK: Phase I/II Study of Entrectinib in Children and Young Adults with Aggressive Solid or Brain Tumors
Diseases Treated:
Solid tumors, brain tumors, CNS tumors
Eligibility:
- Diagnosed with one of the following:
- Relapsed or refractory extracranial solid tumor
- Primary brain tumor with NTRK1/2/3, ROS1 or ALK gene fusion
- Extracranial solid tumor with NTRK1/2/3, ROS1 or ALK gene fusion
- Younger than 22 years old
- Not pregnant
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