Irinotecan in Treating Patients With Recurrent Glioma
- Conditions
- Brain and Central Nervous System Tumors
- Interventions
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
Not provided
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
Siouxland Hematology-Oncology
🇺🇸Sioux City, Iowa, United States
CCOP - Geisinger Clinical and Medical Center
🇺🇸Danville, Pennsylvania, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
CentraCare Clinic
🇺🇸Saint Cloud, Minnesota, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
CCOP - Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
CCOP - Cedar Rapids Oncology Project
🇺🇸Cedar Rapids, Iowa, United States
CCOP - Ann Arbor Regional
🇺🇸Ann Arbor, Michigan, United States
CCOP - Ochsner
🇺🇸New Orleans, Louisiana, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
CCOP - Toledo Community Hospital Oncology Program
🇺🇸Toledo, Ohio, United States
Altru Health Systems
🇺🇸Grand Forks, North Dakota, United States
Quain & Ramstad Clinic, P.C.
🇺🇸Bismarck, North Dakota, United States
CCOP - Merit Care Hospital
🇺🇸Fargo, North Dakota, United States
CCOP - Sioux Community Cancer Consortium
🇺🇸Sioux Falls, South Dakota, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States