Brain Tumor Clinical Trials

 

St. Jude Clinical Trials

RERTEP: Surgery and Second-Course Radiation Therapy in Treating Younger Patients With Recurrent Ependymoma

Diseases Treated:

Recurrent ependymoma

Eligibility:

  • Participant aged 1-21 years at the time of enrollment.
  • Participant has histologically proven progressive Ependymoma after prior focal irradiation.
  • Participant did not receive prior craniospinal irradiation.
  • Participant is not pregnant.
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RT2CR: Limited Surgery and Proton Beam Radiation Therapy in Treating Younger Patients with Brain Tumors

Diseases Treated:

Craniopharyngioma

Eligibility:

  • 21 years of age or younger
  • Diagnosis of craniopharyngioma 
  • Has not been previously treated with radiation therapy
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RT3CR: Proton Therapy for Pediatric Craniopharyngioma

Diseases Treated:

Craniopharyngioma

Eligibility:

  • 21 years old or younger
  • Diagnosis of craniopharyngioma
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SJATRT: Phase 2 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
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SJHG12: Crizotinib and Dasatinib in Treating Younger Patients with Recurrent or Progressive Diffuse Intrinsic Pontine Glioma or High-Grade Glioma

Diseases Treated:

Progressive or recurrent pontine glioma or high-grade glioma

Eligibility:

  • Between 2 and 21 years of age
  • Diagnosis of diffuse intrinsic pontine glioma (DIPG) or high-grade glioma
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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
  • Must be least 3 but not more than 22 years of age
  • Has not received previous treatment with radiation therapy or chemotherapy
  • Must start treatment within 36 days of surgery to remove the tumor
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SJYC07: Risk-Adapted Therapy in Treating Young Children with Brain Tumors

Diseases Treated:

ATRT, PNET, medulloblastoma and other embryonal brain tumors, high-grade glioma, choroid plexus carcinoma or ependymoma

Eligibility:

  • Newly diagnosed brain tumor or tumor of the central nervous system and less than 3 years of age
  • Children between 3 and 5 years old with medulloblastoma  that has not spread  into the fluid that surrounds the brain and spinal cord can also be treated on this trial
  • No prior radiation therapy or chemotherapy
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Collaborative Clinical Trials

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.
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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.
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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
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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.
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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
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EZH102: Tazemetostat in Children and Young Adults with Synovial Sarcoma or INI1-Negative Tumors

Diseases Treated:

Eligibility:

  • Between 6 months and 21 years old
  • Relapsed or refractory rhabdoid tumors, INI1-negative tumors or synovial sarcoma
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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.
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PBTC29: Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma

Diseases Treated:

Gliomas

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.
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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.
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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:

  • Participant between four (4) and twenty-one (21) years of age at time of enrollment.
  • Participant has histologically confirmed Rb1 positive recurrent, progressive, or refractory CNS tumor or DIPG.
  • Participant with a neurological deficit that is stable for at least one (1) week prior to enrollment.
  • Participant has received last dose of known myelosuppressive anticancer chemotherapy at least three (3) weeks prior to enrollment.
  • Participant has received last fraction of focal irradiation > two (2) weeks prior to enrollment.
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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
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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 nitrosurea.
  • Participant received his or her last dose of other investigational or biological agent more than seven (7) days prior to study entry.
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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:

  • Participant enrolling on the MTD cohort is less than eight-teen (18) years of age at registration or if enrolling on the expansion cohort is less than or equal to twenty-five (25) years of age at time of registration.
  • Participant has histologically confirmed diagnosis of glioma (WHO Grades I-IV).
  • Participant tumor has tested positive for the BRAFV600E mutation at a CLIA approved laboratory.
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