Spots Global Cancer Trial Database for Irinotecan Plus Carmustine in Treating Patients With Recurrent Primary Malignant Glioma

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Trial Identification

Brief Title: Irinotecan Plus Carmustine in Treating Patients With Recurrent Primary Malignant Glioma

Official Title: Phase I Treatment of Adults With Primary Malignant Glioma With Irinotecan (CPT-11) (NSC #6616348) Plus BCNU (NSC #409962)

Study ID: NCT00002988

Conditions

Brain and Central Nervous System Tumors

Interventions

carmustine

irinotecan hydrochloride

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of irinotecan plus carmustine in treating patients who have recurrent primary malignant glioma.

Detailed Description: 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.