Irinotecan Plus Carmustine in Treating Patients With Recurrent Primary Malignant Glioma
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|ClinicalTrials.gov Identifier: NCT00002988|
Recruitment Status : Completed
First Posted : May 19, 2004
Last Update Posted : June 20, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: carmustine Drug: irinotecan hydrochloride||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Official Title:||Phase I Treatment of Adults With Primary Malignant Glioma With Irinotecan (CPT-11) (NSC #6616348) Plus BCNU (NSC #409962)|
|Study Start Date :||April 1997|
|Primary Completion Date :||November 2000|
|Study Completion Date :||November 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002988
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Study Chair:||Henry S. Friedman, MD||Duke Cancer Institute|