Brain Tumor Clinical Trials

 

St. Jude Clinical Trials

HALGG: Hippocampal-Avoidance Using Proton Therapy in Children with Brain Tumors

Diseases Treated:

 Low-grade glioma

Eligibility:

  • At least 6 years old and younger than 22
  • Diagnosis of low-grade glioma
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MEMCRT: Memantine to Prevent Thinking Problems in Children Receiving Radiation for Certain Brain Tumors

Diseases Treated:

Brain Tumors

Eligibility:

  • Between 6 and 21 years old
  • Diagnosis of localized low-grade gliomacraniopharyngioma, 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
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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
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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 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
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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
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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:

Medulloblastoma

Eligibility:

Eligibility Overview

  • Recurrent, refractory or progressive medulloblastoma
  • At least 1 year old and younger than 25 years old
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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
  • 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
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SJPI3K: Phase I Study of GDC-0084 in Young Patients with Newly Diagnosed DIPG or other Gliomas after Radiation Therapy

Diseases Treated:

DIPG, diffuse midline glioma, H3 K27M-mutant glioma

Eligibility:

  • Between 2 and 22 years old
  • Diagnosed with diffuse intrinsic pontine glioma (DIPG) or other midline glioma that has not spread
  • No prior therapy, other than surgery and/or steroids
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Collaborative Clinical Trials

ACNS1721: A Study of the Drug Veliparib with Radiation Therapy in Patients with Newly Diagnosed High-Grade Glioma

Diseases Treated:

High-grade glioma

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
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DRBHGG: Combination Chemotherapy for Low Grade Glioma (LGG) and Relapsed or Refractory High Grade Glioma (HGG) Brain Tumors

Diseases Treated:

High grade glioma (HGG), low grade glioma (LGG)

Eligibility:

  • At least 12 months old and younger than 18 years of age
  • High grade glioma with BRAF V600 mutation that has relapsed, progressed or failed to respond to therapy OR
  • Newly diagnosed Low grade glioma with BRAF V600 mutation that is not treatable with surgery and no previous treatment with chemotherapy, radiotherapy or targeted agents.
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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
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LOXORET: Phase I/II Study of LOXO-292 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
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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
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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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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

 

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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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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
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PBTC49: Study of Savolitinib in Recurrent, Progressive or Refractory Medulloblastoma, HGG or DIPG

Diseases Treated:

Medulloblastoma

High-grade glioma (HGG)

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
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