Spots Global Cancer Trial Database for SU-101 Compared With Procarbazine in Treating Patients With Glioblastoma Multiforme
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Trial Identification
Brief Title: SU-101 Compared With Procarbazine in Treating Patients With Glioblastoma Multiforme
Official Title: A Phase III Randomized Study of SU101 Versus Procarbazine for Patients With Glioblastoma Multiforme in First Relapse
Study ID: NCT00003293
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether SU-101 is more effective than procarbazine in treating patients with glioblastoma multiforme. PURPOSE: Randomized phase III trial to compare the effectiveness of SU-101 with that of procarbazine in treating patients with glioblastoma multiforme that has recurred.
Detailed Description: OBJECTIVES: I. Compare the median survival of patients with glioblastoma multiforme in first relapse treated with intravenous leflunomide (SU101) administered as a loading dose with weekly maintenance therapy versus oral, single-agent procarbazine administered daily for 28 days every 56 days. II. Compare the median time to progression for these regimens in these patients. III. Assess the objective response of these patients. IV. Assess the safety of SU101 given on this schedule. V. Describe the health-related quality of life of these patients. OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified according to performance status (Karnofsky 60-80% vs 90-100%), age (less than 50 vs 50 and over), and time from initial diagnosis to recurrence (6 months or greater vs less than 6 months). Patients are randomized to one of two treatment arms. Arm I: Patients receive leflunomide (SU101) IV over 6 hours daily on days 1-4, again 4-8 days later, and weekly thereafter for a total of 4 loading dose infusions and six maintenance infusions in course 1. Patients receive 7 weekly maintenance infusions of SU101 in courses thereafter. Treatment repeats every 8 weeks. Arm II: Patients receive procarbazine orally once or twice daily for 4 weeks. Treatment is repeated every 8 weeks. All patients complete a health-related quality-of-life questionnaire every 8 weeks and at study withdrawal. Treatment courses continue up to a maximum of 1 year in the absence of unacceptable toxicity or disease progression. Patients are followed every 2 months, beginning 30 days after study completion. PROJECTED ACCRUAL: A maximum of 380 patients will be accrued for this study.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States
Arizona Cancer Center, Tucson, Arizona, United States
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
Beckman Research Institute, City of Hope, Los Angeles, California, United States
St. Francis Hospital, San Francisco, California, United States
University of Colorado Cancer Center, Denver, Colorado, United States
Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Medical College of Georgia Hospital and Clinics, Augusta, Georgia, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
University of Iowa College of Medicine, Iowa City, Iowa, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center, Worcester, Massachusetts, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Henry Ford Hospital, Detroit, Michigan, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Cancer Center of Albany Medical Center, Albany, New York, United States
Albert Einstein Comprehensive Cancer Center, Bronx, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Herbert Irving Comprehensive Cancer Center, New York, New York, United States
Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina, United States
Barrett Cancer Center, The University Hospital, Cincinnati, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, United States
Western Pennsylvania Cancer Institute, Pittsburgh, Pennsylvania, United States
Rhode Island Hospital, Providence, Rhode Island, United States
Vanderbilt Cancer Center, Nashville, Tennessee, United States
Simmons Cancer Center - Dallas, Dallas, Texas, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
University of Washington Medical Center, Seattle, Washington, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Cross Cancer Institute, Edmonton, Alberta, Canada
Cancer Care Ontario-London Regional Cancer Centre, London, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Contact Details
Name: Alison L. Hannah, MBBS
Affiliation: SUGEN
Role: STUDY_CHAIR
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