A Phase II Open Label Study of SU101 for Patients With Anaplastic Astrocytoma in First Relapse
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.
Interventional
Primary Purpose: Treatment
Alison L. Hannah, MBBS
Study Chair
SUGEN
United States: Food and Drug Administration
SUGEN-SU101.021
NCT00003775
December 1998
May 2006
Name | Location |
---|---|
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 |
USC/Norris Comprehensive Cancer Center | Los Angeles, California 90033-0800 |
University of Colorado Cancer Center | Denver, Colorado 80262 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
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 |
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 |
Henry Ford Hospital | Detroit, Michigan 48202 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
St. Joseph's Hospital and Medical Center | Phoenix, Arizona 85001-2071 |
Mount Sinai Comprehensive Cancer Center | Miami Beach, Florida 33140 |
University of Iowa College of Medicine | Iowa City, Iowa 52242 |
Western Pennsylvania Cancer Institute | Pittsburgh, Pennsylvania 15224 |
New York Neurological Institute | New York, New York 10032 |