ACNS1221 A Phase II Study for the Treatment of Non-Metastatic NodularDesmoplastic Medulloblastoma in Children Less Than 4 Years of Age
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 or by stopping them from dividing.
Ages Eligible for Study: up to 47 Months Genders Eligible for Study: Both Accepts Healthy Volunteers: No Criteria Inclusion Criteria: â?¢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 â?¢Patient must have negative lumbar cerebrospinal fluid (CSF) cytology (lumbar CSF must be obtained unless medically contraindicated); CSF cytology for staging should be performed no sooner than 14 days post operatively, preferably between day 14 and day 21 to allow for final staging status before enrollment onto the study â?¢Patients must have: â?¦Pre-operative cranial magnetic resonance imaging (MRI) (recommended with gadolinium) or pre-operative computed tomography (CT) (recommended with contrast) â?¦Post-operative cranial MRI with and without gadolinium within 72 hours of surgery â?¦Spinal MRI pre-op with and without gadolinium or post-op with and without gadolinium within 72 hours of surgery â?¢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 â?¢Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2; use Lansky for patients equal to less than 16 years of age â?¢Patients must have a life expectancy of greater than equal to 8 weeks â?¢Patients who are receiving dexamethasone must be on a stable dose for at least 1 week prior to study entry â?¢Peripheral absolute neutrophil count (ANC) greater than equal to 1000/uL â?¢Platelet count greater than equal to 100,000/uL (transfusion independent) â?¢Hemoglobin greater than equal to 10.0 g/dL (may receive red blood cell [RBC] transfusions) â?¢Creatinine clearance or radioisotope glomerular filtration rate (GFR) greater than equal to 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows: â?¦1 month to less than 6 months: 0.4 mg/dL â?¦6 months to less than 1 year: 0.5 mg/dL â?¦1 to less than 2 years: 0.6 mg/dL â?¦2 to less than 6 years: 0.8 mg/dL â?¢Total bilirubin equal to less than 1.5 x upper limit of normal (ULN) for age â?¢Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) less than 2.5 x upper limit of normal (ULN) for age â?¢Central nervous system function defined as: â?¦Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled â?¦Patients must not be in status, coma or assisted ventilation prior to study enrollment Exclusion Criteria: â?¢Patients with metastatic disease by either MRI evaluation (brain and spine) or lumbar CSF cytology are not eligible â?¢Patients must not have received any prior tumor-directed therapy other than surgical intervention and corticosteroids
INDUCTION THERAPY: Patients receive vincristine sulfate intravenously (IV) over 1 minute or infused via minibag on days 1, 15, and 29; cyclophosphamide IV over 1 hour on days 1-3; methotrexate IV over 24 hours on days 15 and 29; etoposide IV over 60-120 minutes on days 43-45; and carboplatin IV over 1 hour on days 43-45. Treatment repeats every 63 days for 3 courses in the absence of disease progression or unacceptable toxicity. CONTINUATION THERAPY: Patients receive vincristine sulfate IV over 1 minute or infused via minibag on day 1, cyclophosphamide IV over 1 hour on days 1-3, etoposide IV over 60-120 minutes on days 21-23, and carboplatin IV over 1 hour on days 21-23. Treatment repeats every 42 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 3, 6, 9, 12, 16, 20, 24, 36, 48, 60, and 72 months.
11/23/2014 04:07 AM