Irinotecan in Treating Patients With Recurrent Glioma

Phase 2

Completed

• Conditions: Brain and Central Nervous System Tumors
• Interventions: Drug: irinotecan hydrochloride

• Registration Number: NCT00003134
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief 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.

Detailed 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 Timeline

• Study Start: 1998-01
• Study First Submitted: 1999-11-01
• Primary Completion: 2001-10
• Study First Submitted QC: 2004-09-03
• Study First Posted: 2004-09-06
• Study Completion: 2009-01
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-05
• Last Update Posted: 2016-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II: irinotecan	irinotecan hydrochloride	Patients receive irinotecan on day 1 every 3 weeks for up to 12 courses. Patients 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. Patients are followed every 3 months for the first year, every 6 months for the next 4 years, then annually until death.
Arm I: irinotecan	irinotecan hydrochloride	Patients 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 who received prior nitrosoureas, also receive reduced starting doses of irinotecan. The dosages may be increased once per patient after the first course if toxic effects are acceptable. Patients are followed every 3 months for the first year, every 6 months for the next 4 years, then annually until death.

Primary Outcome Measures

Name	Time	Method
Overall survival	Up to 10 years

Trial Locations

Locations (19)

CCOP - Scottsdale Oncology Program; 🇺🇸 Scottsdale, Arizona, United States

CCOP - Illinois Oncology Research Association; 🇺🇸 Peoria, Illinois, United States

CCOP - Carle Cancer Center; 🇺🇸 Urbana, Illinois, United States

CCOP - Cedar Rapids Oncology Project; 🇺🇸 Cedar Rapids, Iowa, United States

CCOP - Iowa Oncology Research Association; 🇺🇸 Des Moines, Iowa, United States

Siouxland Hematology-Oncology; 🇺🇸 Sioux City, Iowa, United States

CCOP - Wichita; 🇺🇸 Wichita, Kansas, United States

CCOP - Ochsner; 🇺🇸 New Orleans, Louisiana, United States

CCOP - Ann Arbor Regional; 🇺🇸 Ann Arbor, Michigan, United States

CCOP - Duluth; 🇺🇸 Duluth, Minnesota, United States

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