St. Jude Clinical Trials
MEMCRT: Memantine to Prevent Thinking Problems in Children Receiving Radiation for Certain Brain Tumors
- 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
RERTEP: Surgery and Second-Course Radiation Therapy in Treating Younger Patients With Recurrent Ependymoma
- 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
- 21 years of age or younger
- Diagnosis of craniopharyngioma
- Has not been previously treated with radiation therapy
- 21 years old or younger
- Diagnosis of craniopharyngioma
- 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
Medulloblastoma (includes all variants of medulloblastoma and posterior fossa PNET)
- 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
Collaborative Clinical Trials
ADV1217: WEE1 Inhibitor MK-1775 and Local Radiation Therapy in Treating Younger Patients With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas
Newly diagnosed Diffuse Intrinsic Pontine Glioma (DIPG)
- 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.
- 12 months old or older and younger than 21 years old
- 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
- 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
Brain Tumor : Previously treated brain tumors
- 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
Newly diagnosed localize primary NGGCT or newly diagnosed localized germinoma
- 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
- 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
- Between 6 months and 21 years old
- Relapsed or refractory rhabdoid tumors, INI1-negative tumors or synovial sarcoma
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
Relapsed or refractory solid tumor
- 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.
- 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
Unresectable or recurrent craniopharyngioma
- 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
- 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
- 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
- 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)
Recurrent or progressive low grade gliomas (brain tumors)
- 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)]
Brain tumors (recurrent and refractory)
- 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