Clinical Trial Details
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NCT00602667 : Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma
PhasePhase 2
AgesMin: N/A Max: 5 Years
Histologically confirmed newly diagnosed CNS tumors of any of the following :

- Medulloblastoma (all histologic subtypes, including medullomyoblastoma and melanotic

- 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

- 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


- 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


- See Disease Characteristics

- No more than 31 days since prior definitive surgery

- No prior radiotherapy or chemotherapy other than corticosteroid therapy
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