A Phase III Randomized Study of SU101 Versus Procarbazine for Patients With Glioblastoma Multiforme in First Relapse
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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Alison L. Hannah, MBBS
Study Chair
SUGEN
United States: Food and Drug Administration
SUGEN-SU101.015
NCT00003293
February 1998
May 2001
Name | Location |
---|---|
Arizona Cancer Center | Tucson, Arizona 85724 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Albert Einstein Comprehensive Cancer Center | Bronx, New York 10461 |
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
USC/Norris Comprehensive Cancer Center | Los Angeles, California 90033-0800 |
University of Colorado Cancer Center | Denver, Colorado 80262 |
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
University of Massachusetts Memorial Medical Center | Worcester, Massachusetts 01655 |
Cancer Center of Albany Medical Center | Albany, New York 12208 |
Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
Barrett Cancer Center, The University Hospital | Cincinnati, Ohio 45219 |
Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
Simmons Cancer Center - Dallas | Dallas, Texas 75235-9154 |
University of Washington Medical Center | Seattle, Washington 98195-6043 |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
Rhode Island Hospital | Providence, Rhode Island 02903 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Vanderbilt Cancer Center | Nashville, Tennessee 37232-6838 |
Henry Ford Hospital | Detroit, Michigan 48202 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
St. Joseph's Hospital and Medical Center | Phoenix, Arizona 85001-2071 |
Beckman Research Institute, City of Hope | Los Angeles, California 91010 |
Herbert Irving Comprehensive Cancer Center | New York, New York 10032 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Mount Sinai Comprehensive Cancer Center | Miami Beach, Florida 33140 |
St. Francis Hospital | San Francisco, California 94109 |
Medical College of Georgia Hospital and Clinics | Augusta, Georgia 30912-3620 |
University of Iowa College of Medicine | Iowa City, Iowa 52242 |
Western Pennsylvania Cancer Institute | Pittsburgh, Pennsylvania 15224 |