Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed, Non-metastatic Desmoplastic Medulloblastoma
Condition: Desmoplastic/Nodular Medulloblastoma; Medulloblastoma; Medulloblastoma With Extensive Nodularity; Nevoid Basal Cell Carcinoma Syndrome
MeSH terms: Carcinoma, Basal Cell; Medulloblastoma; Basal Cell Nevus Syndrome
Intervention: Carboplatin; Cognitive Assessment; Cyclophosphamide; Etoposide; Laboratory Biomarker Analysis; Methotrexate; Vincristine Sulfate
Intervention description: Given IV; Optional ancillary studies; Given IV; Given IV; Correlative studies; Given IV; Given IV
Intervention MeSH terms: Cyclophosphamide; Carboplatin; Methotrexate; Etoposide; Vincristine; Etoposide phosphate; Podophyllotoxin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Maximum age: 47 Months
Healthy volunteers: No

Summary:

      This phase II trial studies how well combination chemotherapy works in treating younger
      patients with newly diagnosed, non-metastatic desmoplastic medulloblastoma. Drugs used in
      chemotherapy, such as vincristine sulfate, cyclophosphamide, methotrexate, etoposide, and
      carboplatin, work in different ways to stop the growth of tumor cells, either by killing the
      cells, by stopping them from dividing, or by stopping them from spreading.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be newly diagnosed and have a confirmed histologic diagnosis of nodular
             desmoplastic (ND) medulloblastoma or medulloblastoma with extensive nodularity (MBEN)
             from rapid central pathology screening review; please note: patients with Gorlin
             syndrome are eligible

          -  Patient must have negative lumbar cerebrospinal fluid (CSF) cytology (lumbar CSF must
             be obtained unless medically contraindicated); CSF cytology for staging should be
             performed preferably no sooner than 14 days post operatively to avoid false positive
             CSF, ideally, CSF should be obtained between day 14 and day 21 to allow for final
             staging status before enrollment onto the study; Note: patients with positive CSF
             cytology obtained prior to 14 days after surgery may have cytology repeated to
             determine eligibility and final CSF status

          -  Patients must have:

               -  Pre-operative cranial magnetic resonance imaging (MRI) (recommended with
                  gadolinium) or pre-operative computed tomography (CT) (recommended with contrast)

               -  Post-operative cranial MRI with and without gadolinium within 72 hours of surgery

               -  Spinal MRI pre-op with and without gadolinium or post-op with and without
                  gadolinium preferably within 72 hours of surgery

          -  Patients must be enrolled on study within 31 days of definitive surgical resection at
             which time tissue is acquired to determine a diagnosis; patients must be enrolled
             before treatment begins; the date protocol therapy is projected to start must be no
             later than five (5) calendar days after the date of study enrollment; patients who are
             started on protocol therapy on a Phase II study prior to study enrollment will be
             considered ineligible

          -  Patients must have a performance status corresponding to Eastern Cooperative Oncology
             Group (ECOG) scores of 0, 1 or 2; use Lansky for patients =< 16 years of age

          -  Patients must have a life expectancy of >= 8 weeks

          -  Patients who are receiving dexamethasone must be on a stable dose for at least 1 week
             prior to study entry

          -  Peripheral absolute neutrophil count (ANC) >= 1000/uL

          -  Platelet count >= 100,000/uL (transfusion independent)

          -  Hemoglobin >= 10.0 g/dL (may receive red blood cell [RBC] transfusions)

          -  Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
             mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:

               -  1 month to < 6 months: 0.4 mg/dL

               -  6 months to < 1 year: 0.5 mg/dL

               -  1 to < 2 years: 0.6 mg/dL

               -  2 to < 6 years: 0.8 mg/dL

          -  Total bilirubin =< 1.5 x upper limit of normal (ULN) for age

          -  Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or
             serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x
             upper limit of normal (ULN) for age

          -  Central nervous system function defined as:

               -  Patients with seizure disorder may be enrolled if on anticonvulsants and well
                  controlled

               -  Patients must not be in status, coma or assisted ventilation prior to study
                  enrollment

        Exclusion Criteria:

          -  Patients with metastatic disease by either MRI evaluation (brain and spine) or lumbar
             CSF cytology are not eligible

          -  Patients must not have received any prior tumor-directed therapy other than surgical
             intervention and corticosteroids