Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma
About the study
Who can take part
EXCLUSION CRITERIA
- Medulloblastoma (all histologic subtypes, including medullomyoblastoma and melanotic medulloblastoma)
- Supratentorial primitive neuroectodermal tumor (PNET) (including CNS neuroblastoma or ganglioneuroblastoma, medulloepithelioma, and ependymoblastoma)
- Pineoblastoma
- Atypical teratoid rhabdoid tumor (ATRT)
- Choroid plexus carcinoma
- High grade glioma (including anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic ganglioglioma, pleomorphic xanthoastrocytoma with anaplastic features, high-grade astroblastoma , anaplastic pilocytic astrocytoma, malignant glioneuronal tumor, glioblastoma multiforme), or gliosarcoma,
- Ependymoma (including all ependymoma histological variants)
Age < 3 years at time of diagnosis for all histological diagnosis. Medulloblastoma patients ≥ 3 and < 5years old at diagnosis who have non-metastatic disease with no more than 1cm2 of residual tumor are also eligible.
Meets criteria for 1 of the following risk groups:
Low-risk group:
Histologically confirmed nodular desmoplastic medulloblastoma, including medulloblastoma with extensive nodularity
Focal areas of anaplasia or other atypical features suggesting more aggressive phenotype in a tumor otherwise considered nodular desmoplastic should be treated on the intermediate-risk group, with final risk stratification at the discretion of principal investigator and study pathologist
No evidence of CNS metastasis 7 to 28 days after surgery by MRI and cytologic examination of lumbar cerebrospinal fluid (CSF)
- Ventricular CSF from a shunt or Ommaya reservoir may be used to rule out M1 disease when lumbar puncture is medically contraindicated
- Intermediate-risk group assignment when there is no other evidence of metastasis and CSF sampling is not possible
- Gross total resection, defined as residual tumor or imaging abnormality (not definitive for residual tumor) with a size of < 1 cm2 confirmed on postoperative CT scan or MRI
- Brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size < 1 cm2) and otherwise meets criteria for the low-risk group, the patient will be classified as low-risk
- Desmoplastic medulloblastoma patients who are ≥3 -<5 years of age will NOT be eligible for the low risk arm of the protocol.
Intermediate-risk group:
- Histologically confirmed nodular desmoplastic medulloblastoma with less than gross total resection and no evidence of metastasis
- Any eligible histologic diagnosis other than desmoplastic medulloblastoma with no evidence of CNS metastasis
- Medulloblastoma patients who are ≥3 and < 5 yrs of age irrespective of histology and with no evidence of CNS metastasis
High-risk group:
- Any eligible histologic diagnosis with evidence of CNS metastasis
- Patients with extraneural metastasis are eligible for treatment on the high-risk group
PATIENT CHARACTERISTICS:
- Lansky performance status ≥ 30 (except for posterior fossa syndrome)
- WBC > 2,000/mm3
- Platelets > 50,000/mm3 (without support)
- Hemoglobin > 8 g/dL (with or without support)
- ANC > 500/mm3
- Serum creatinine < 3 times upper limit of normal (ULN)
- ALT < 5 times ULN
- Total bilirubin < 3 times ULN
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No more than 31 days since prior definitive surgery
- No prior radiotherapy or chemotherapy other than corticosteroid therapy

Study Locations
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How to Apply
Study’s details
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