Leflunomide in Treating Patients With Anaplastic Astrocytoma in First Relapse
- Conditions
- Brain and Central Nervous System Tumors
- Registration Number
- NCT00003775
- Lead Sponsor
- Pfizer
- 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 leflunomide in treating patients who have anaplastic astrocytoma in first relapse.
- Detailed Description
OBJECTIVES: I. Determine the median time to progression, median survival, and objective response of patients with anaplastic astrocytoma or anaplastic oligoastrocytoma in first relapse treated with intravenous leflunomide (SU101). II. Assess the safety of SU101 in these patients. III. Describe the health-related quality of life of patients treated with intravenous SU101.
OUTLINE: This is an open label, multicenter study. Patients receive leflunomide (SU101) IV over 6 hours on days 1-4. Patients then receive SU101 IV over 6 hours weekly for 6 weeks (beginning between days 8-12). Patients exhibiting complete response, partial response, or stable disease may continue on treatment for up to a year or until disease progression or unacceptable toxicity occurs. Patients continuing therapy receive SU101 IV over 6 hours every week for 7 weeks, followed by 1 week of rest. Quality of life is assessed every 8 weeks and at the end of the study. Patients are followed every 8 weeks or until tumor progression.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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 (26)
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
USC/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Mount Sinai Comprehensive Cancer Center
🇺🇸Miami Beach, Florida, United States
Cancer Center of Albany Medical Center
🇺🇸Albany, New York, United States
St. Joseph's Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
Cancer Care Ontario-London Regional Cancer Centre
🇨🇦London, Ontario, Canada
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Barrett Cancer Center, The University Hospital
🇺🇸Cincinnati, Ohio, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
University of Iowa College of Medicine
🇺🇸Iowa City, Iowa, United States
Albert Einstein Comprehensive Cancer Center
🇺🇸Bronx, New York, United States
New York Neurological Institute
🇺🇸New York, New York, United States
British Columbia Cancer Agency
🇨🇦Vancouver, British Columbia, Canada
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
🇺🇸Chicago, Illinois, United States
Western Pennsylvania Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States