Fenretinide in Treating Patients With Recurrent Malignant Glioma
- Conditions
- Brain and Central Nervous System Tumors
- Registration Number
- NCT00006080
- 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 fenretinide in treating patients who have recurrent malignant glioma.
- Detailed Description
OBJECTIVES: I. Determine the efficacy of fenretinide as assessed by 6-month progression- free survival in patients with recurrent malignant glioma. II. Determine the rate of measurable clinical response, time to progression, and overall survival of patients treated with this drug. III. Determine the unexpected toxicity of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to disease type (glioblastoma multiforme (closed to accrual as of 05/31/2001) and gliosarcoma (closed to accrual as of 05/31/2001) vs anaplastic astrocytoma, anaplastic oligodendroglioma, and mixed malignant glioma). Patients receive oral fenretinide twice daily during weeks 1 and 4. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then before each course of chemotherapy. Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 41-85 patients (21-45 with anaplastic astrocytoma, anaplastic oligodendroglioma, and mixed malignant glioma and 20-40 with glioblastoma multiforme (closed to accrual as of 05/31/2001) and gliosarcoma (closed to accrual as of 05/31/2001)) will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
🇺🇸Bethesda, Maryland, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
University of Pittsburgh Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States