Status and phase
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Funder types
Identifiers
About
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy and radiation therapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy or radiation therapy and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy with topotecan, cyclophosphamide, cisplatin, and vincristine plus radiation therapy and peripheral stem cell transplantation in treating children with newly diagnosed medulloblastoma or supratentorial primitive neuroectodermal tumor.
Full description
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 treatment groups based on risk status.
Patients are followed at 1, 2, 4, 6, 9, 12, 15, 18, and 24 months and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 12-36 patients will be accrued for this study within 5 years.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically proven medulloblastoma or supratentorial primitive neuroectodermal tumor
Average-risk group:
High-risk group:
No bone involvement by bone scan
Must begin study within 28 days of definitive surgery
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Primary purpose
Allocation
Interventional model
Masking
94 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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