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 histologic or 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 of the brain or spinal cord
• •Medulloblastoma
• •* Posterior fossa classic, desmoplastic or extensive nodular or anaplastic/large cell medulloblastoma with appropriate and sufficient tumor material (FFPE or snap frozen) for proposed assays: all stages, age less than 6 years at diagnosis
• •* Posterior fossa classic or anaplastic/large cell medulloblastoma with sufficient tumor material (FFPE or snap frozen) for proposed assays: clinically high-stage (neuraxis or extra-neural dissemination, M1-4), age greater than 6 years to less than 10 years at diagnosis
• •CNS Embryonal Tumors:
• •\- Pineoblastoma, CNS neuroblastoma, CNS ganglioneuroblastoma, embryonal tumor with multi-layered rosettes (ETMR, including embryonal tumor with abundant neuropil and true rosettes (ETANTR), ependymoblastoma and ETMR not otherwise specified), medulloepithelioma, CNS embryonal tumor with rhabdoid features (INI1 intact) and CNS embryonal tumor, not otherwise specified.
• •Must commence Induction chemotherapy within 28 days of the most recent definitive surgical procedure and within 21 days of the most recent neuro-imaging studies (MRI of 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's Syndrome of indirect hyperbilirubinemia) and transaminases \[SGPT or ALT, and SGOT or AST\] less than 2.5 (two and a half) times the upper limits of institutional normal.
• •* Renal: Creatinine clearance and/or glomerular filtration rate (GFR) greater than 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 of banded neutrophils + segmented neutrophils + metamyelocytes + monocytes + eosinophils Please note, if institution reports differential as a percentage, then APC = \[percentage of banded neutrophils + segmented neutrophils+ metamyelocytes+monocytes+eosinophils\] x total white cell count.
• •2. Platelet Count \> 100,000/µL (transfusion independent)
• •3. Hemoglobin \> 8 gm/dL (may have received RBC transfusions).