Irinotecan in Treating Patients With Recurrent Glioma

Brain and Central Nervous System Tumors Clinical Trial

Official title: A Phase II Trial of Irinotecan in Recurrent Glioma

Status Completed

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have recurrent glioma.

Clinical Trial Description

OBJECTIVES: I. Determine the efficacy of irinotecan in the treatment of patients with recurrent glioma. II. Assess the toxicities of irinotecan in these patients. III. Correlate the pharmacological parameters with toxicity and response to therapy.

OUTLINE: This is a two arm study. Patients are stratified according to prior nitrosourea administration. Patients are assigned to 1 of 2 arms, with only 1 arm being open at any time. Patients assigned to arm I receive irinotecan IV over 90 minutes on days 1, 8, 15, and

22. This is followed by a 2 week rest and continues for a maximum of 6 courses. Patients assigned to arm II receive irinotecan on day 1 every 3 weeks for up to 12 courses. Patients in both arms who received prior nitrosoureas receive reduced starting doses of irinotecan. The dosages may be increased once per patient after the first course if toxic effects are acceptable. Arm I closed as of 10/98, Arm II open as of 10/98. Patients are followed every 3 months for the first year, every 6 months for the next 4 years, then annually until death. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Glioma
• Nervous System Neoplasms

• NCT number: NCT00003134
• Study type: Interventional
• Source: Alliance for Clinical Trials in Oncology
• Status: Completed
• Phase: Phase 2
• Start date: January 1998
• Completion date: January 2009