NCT00003301

Irinotecan in Treating Patients With Recurrent Malignant Glioma

A Dose Finding and Safety/Efficacy Trial of CPT-11 (Irinotecan) in Patients With Recurrent Malignant Gliomas

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: New Approaches to Brain Tumor Therapy Consortium · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I/II trial to study the effectiveness of irinotecan in treating patients with recurrent malignant glioma.

Detailed description

OBJECTIVES: I. Determine the maximum tolerated dose of intravenous irinotecan when administered weekly for 4 weeks in patients with recurrent malignant gliomas. II. Describe the pharmacokinetics of this route of administration, measuring both irinotecan and the active metabolite SN-38, and determine the effects of hepatic enzyme inducing drugs, such as anticonvulsants, on the pharmacokinetics in these patients. III. Determine preliminary response data and activity of irinotecan in this patient population. IV. Correlate response with topoisomerase I levels in brain tumor tissue from patients undergoing treatment. OUTLINE: Patients are stratified based on their use/kind of anticonvulsant drugs. This stratification yields two arms for this study. Arm I consists of patients who use anticonvulsant drugs that induce hepatic metabolic enzymes. Arm II consists of patients who use anticonvulsant drugs that cause modest to no induction of hepatic metabolic enzymes or no anticonvulsant drug. Three patients in each arm receive irinotecan by 90-minute IV infusions every week for 4 weeks, followed by a 2 week rest period. The dose is escalated for the next cohort of 3 patients in the absence of unacceptable dose limiting toxicity. The 6 week course is repeated until unacceptable toxicity or disease progression. Once the maximum tolerated dose has been established for each arm, additional patients are treated at that dose level. Patients are followed every 2 months. PROJECTED ACCRUAL: A minimum of 3 patients will be accrued into the phase I portion of the study and a total of 18-35 patients will be accrued into each arm of the phase II portion of the study.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
DRUG	irinotecan hydrochloride

Timeline

• Start date: 1998-07-01
• Completion: 2004-04-01
• First posted: 2004-04-09
• Last updated: 2013-06-21

Locations

9 sites across 1 country: United States