CAMP 004A - Phase 2 Study Of Intensive Chemotherapy (BET) For Selected Categories Of Malignant Central Nervous System Tumor
- Determine the response rate in patients with central nervous system malignancies
treated with intensive chemotherapy supported by autologous peripheral blood stem cell
transplantation following surgical resection and/or radiotherapy.
- Determine the disease-free survival and overall survival of this patient population
treated with these regimens.
- Determine the toxicity of this high-dose chemotherapy regimen in these patients.
- Assess the quality of life of these patients following these treatment regimens.
OUTLINE: Patients with anaplastic astrocytoma, esthesioneuroblastoma, germ cell tumor, or
primary neuroectodermal tumor undergo initial surgical resection followed by conventional or
stereotactic radiotherapy. Patients with germ cell or primary neuroectodermal tumors also
receive 4 courses of standard chemotherapy comprising cyclophosphamide, etoposide, and
cisplatin prior to high-dose chemotherapy.
All patients undergo peripheral blood stem cell or bone marrow harvest followed by high-dose
chemotherapy consolidation. Patients receive thiotepa IV 3 times daily on days -7 to -3,
carmustine IV over 1 hour on days -6 to -3, and etoposide IV over 5 hours on days -6 to -3.
Patients then undergo transplantation on day 0. Filgrastim (G-CSF) is administered
concurrently with stem cell harvesting and transplantation.
Patients with recurrent oligodendroglioma or CNS lymphoma who have not received radiotherapy
at diagnosis undergo conventional radiotherapy 6 weeks after completion of high-dose
Patients are followed every 2-3 months for 1 year and then annually for 5 years. Quality of
life is assessed at follow-up.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 3 years.
Primary Purpose: Treatment
Charles S. Hesdorffer, MD
Herbert Irving Comprehensive Cancer Center
United States: Federal Government
|Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center||New York, New York 10032|