Combination Chemotherapy Followed By Peripheral Stem Cell Transplant in Treating Young Patients With Newly Diagnosed Supratentorial Primitive Neuroectodermal Tumors or High-Risk Medulloblastoma

Status: Recruiting
Phase: Phase 3
Diagnosis: Pediatric Brain Tumor
NCT ID: NCT00336024 (View complete trial on
DFCI Protocol ID: 07-308


This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work when given before a peripheral stem cell transplant in treating young patients with newly diagnosed supratentorial primitive neuroectodermal tumors or high-risk medulloblastoma. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with a peripheral stem cell transplant may allow more chemotherapy to be given so that more tumor cells are killed. It is not yet known which combination chemotherapy regimen is more effective when given before a peripheral stem cell transplant in treating supratentorial primitive neuroectodermal tumors or medulloblastoma.


Conducting Institutions:
Dana-Farber Cancer Institute, Children's Hospital Boston

Overall PI:
Susan Chi, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP,

Eligibility Criteria

DISEASE CHARACTERISTICS: - Diagnosis of 1 of the following: - High-risk medulloblastoma defined by any of the following: - Residual disease > 1.5 cm² - Lumbar cerebral spinal fluid cytology positive for tumor cells by analysis of fluid collected either before definitive surgery or ≥ 10 days after definitive surgery unless contraindicated - M0 disease in children < 8 months of age at diagnosis - M2 or M3 metastatic disease by MRI - M4 disease - Supratentorial primitive neuroectodermal tumor (PNET) - MRI evidence of spinal disease - Tumor must be negative for INI1 gene - Has undergone definitive surgery within the past 31 days - No atypical teratoid rhabdoid tumors - Biological specimens must be available for correlative laboratory studies PATIENT CHARACTERISTICS: - Life expectancy > 8 weeks - Creatinine clearance or radioisotope glomerular filtration rate ≥ 60 mL/min - Bilirubin ≤ 1.5 times upper limit of normal (ULN) - AST and ALT < 2 times ULN - Shortening fraction ≥ 27% by echocardiogram - Ejection fraction ≥ 47% by radionuclide angiogram - No evidence of dyspnea at rest - Pulse oximetry > 94% on room air - Absolute neutrophil count > 1,000/mm³ - Platelet count > 100,000/mm³ (transfusion independent) - Hemoglobin > 8 g/dL (RBC transfusions allowed) PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No prior radiation therapy or chemotherapy - Prior corticosteroids allowed
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