HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors

Inclusion Criteria:

• Patients 10 years of age at the time of definitive confirmatory eligible histologicor cytologic diagnosis of eligible CNS tumor (brain or spinal cord)

• Patients may not have received irradiation or chemotherapy (except corticosteroids)

• Have histologically proven diagnosis of medulloblastoma or CNS embryonal tumors ofthe brain or spinal cord

• Medulloblastoma

• Posterior fossa classic, desmoplastic or extensive nodular or anaplastic/largecell medulloblastoma with appropriate and sufficient tumor material (FFPE orsnap frozen) for proposed assays: all stages, age less than 6 years atdiagnosis

• Posterior fossa classic or anaplastic/large cell medulloblastoma withsufficient tumor material (FFPE or snap frozen) for proposed assays: clinicallyhigh-stage (neuraxis or extra-neural dissemination, M1-4), age greater than 6years to less than 10 years at diagnosis

• Posterior fossa medulloblastoma, those 6 years of age and above at diagnosis,will only be eligible if they have evidence of neuraxis or extraneuraldissemination. Patients 6 years of age and above with low-stage (standard-risk,M0) medulloblastoma will NOT be eligible for this study, irrespective ofmolecular subgroup and extend of local resection

• CNS Embryonal Tumors:

• Pineoblastoma, CNS neuroblastoma, CNS ganglioneuroblastoma, embryonal tumor withmulti-layered rosettes (ETMR, including embryonal tumor with abundant neuropil andtrue rosettes (ETANTR), ependymoblastoma and ETMR not otherwise specified),medulloepithelioma, CNS embryonal tumor with rhabdoid features (INI1 intact) and CNSembryonal tumor, not otherwise specified.

• Must commence Induction chemotherapy within 28 days of the most recent definitivesurgical procedure and within 21 days of the most recent neuro-imaging studies (MRIof brain, performed with and without gadolinium contrast, and MRI of total spine,performed with gadolinium contrast) and lumbar CSF cytological examination

• Patients must have adequate organ functions at the time of registration:

• Liver: bilirubin less than 1.5 mg/dL (except for patients with Gilbert'sSyndrome of indirect hyperbilirubinemia) and transaminases [SGPT or ALT, andSGOT or AST] less than 2.5 (two and a half) times the upper limits ofinstitutional normal.

• Renal: Creatinine clearance and/or glomerular filtration rate (GFR) greaterthan or equal to 60 mL/min/1.73m² within 21 days of protocol therapy.

• Bone Marrow Function:

1. Peripheral absolute phagocyte count (APC) > 1000/ µL. APC = numbers ofbanded neutrophils + segmented neutrophils + metamyelocytes + monocytes +eosinophils Please note, if institution reports differential as apercentage, then APC = [percentage of banded neutrophils + segmentedneutrophils+ metamyelocytes+monocytes+eosinophils] x total white cellcount.
2. Platelet Count > 100,000/µL (transfusion independent)
3. Hemoglobin > 8 gm/dL (may have received RBC transfusions).

Exclusion Criteria:

• Patients older than 10 years of age at time of diagnosis

• Following diagnoses are not eligible for study enrollment: CNS atypicalteratoid/rhabdoid tumor (AT/RT); all ependymomas including anaplastic ependymomas ofthe brain or spinal cord; all choroid plexus carcinomas; all high-grade glial andglio-neuronal tumors; all primary CNS germ cell tumors; all primary CNS sarcomas;all primary or metastatic CNS lymphomas and solid leukemic lesions (i.e., chloromas,granulocytic sarcomas).

• Patients with unbiopsied diffuse intrinsic pontine tumors will NOT be eligible forthis study.