Phase I Treatment of Adults With Primary Malignant Glioma With Irinotecan (CPT-11) (NSC #6616348) Plus BCNU (NSC #409962)
OBJECTIVES: I. Determine the maximum tolerated dose of irinotecan administered in
combination with a fixed dose of carmustine in patients with recurrent primary malignant
glioma. II. Determine the toxic effects of irinotecan and carmustine in these patients.
OUTLINE: This is a dose escalation study of irinotecan. Patients receive irinotecan IV over
90 minutes weekly on weeks 1-4 and carmustine IV over 1 hour on weeks 1-6. Treatment
continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6
patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is
determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences
dose limiting toxicities.
PROJECTED ACCRUAL: Approximately 18-36 patients will be accrued for this study.
Primary Purpose: Treatment
Henry S. Friedman, MD
Duke Cancer Institute
United States: Federal Government
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|