Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase I Treatment of Adults With Recurrent Supratentorial High Grade Glioma With Gliadel Wafers Plus Irinotecan (CPT-11)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of carmustine wafers plus irinotecan in
treating patients with recurrent supratentorial high grade gliomas.
OBJECTIVES:
- 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
patients.
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
progression.
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
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