Phase I Treatment of Adults With Primary Malignant Glioma With Irinotecan (CPT-11) (NSC- #6616348) Plus Temodar (NSC #362856)
- Determine the maximum tolerated dose of irinotecan administered in combination with
temozolomide in patients with recurrent primary malignant glioma.
- Determine the toxicity of this combination therapy in these patients.
OUTLINE: This is a dose escalation study of irinotecan. Patients are stratified according to
concurrent anticonvulsants (Dilantin, Tegretol, or phenobarbital vs other anticonvulsants or
Patients receive irinotecan IV over 90 minutes on days 1, 8, 15, and 22 and oral
temozolomide on days 1-5. Treatment continues every 43 days 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 preceding that at which 2 of 6
patients experience dose limiting toxicities.
PROJECTED ACCRUAL: Not specified
Primary Purpose: Treatment
Henry S. Friedman, MD
Duke Cancer Institute
United States: Federal Government
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|