Phase I Treatment of Adults With Recurrent Supratentorial High Grade Glioma With Gliadel Wafers Plus Irinotecan (CPT-11)
- Define the maximum tolerated dose of irinotecan given in combination with Gliadel
wafers (carmustine) in patients with recurrent glioblastoma multiforme, anaplastic
astrocytoma, or gliosarcoma.
- Define the toxicity of irinotecan given in combination with Gliadel wafers in these
OUTLINE: This is a dose escalation study.
All patients undergo surgical resection. At the time of surgery, up to eight Gliadel wafers
(containing carmustine) are implanted in the resected tumor cavity.
Cohorts of 3 patients each receive escalating doses of irinotecan IV over 90 minutes once
weekly within 3 weeks after Gliadel wafer implantation. One course of treatment consists of
4 weeks of irinotecan and 2 weeks of rest. If 1 patient experiences dose limiting toxicity
(DLT) at a dose level, an additional 3 patients are entered at that same dose level. If 2
patients experience DLT, the maximum tolerated dose (MTD) has been surpassed and a total of
6 patients are treated at the previous dose level. The MTD is defined as the highest dose in
which no more than 1 of 6 patients experiences DLT.
Treatment continues for up to 12 courses in the absence of unacceptable toxicity and disease
Patients are followed for at least 4 months.
PROJECTED ACCRUAL: Approximately 18 patients will be accrued into this study over 9 months.
Primary Purpose: Treatment
Henry S. Friedman, MD
Duke Cancer Institute
United States: Federal Government
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|