A Multicenter Study to Assess the Efficacy of 506U78 in Patients With Chronic Lymphocytic Leukemia Who Are Refractory to Fludarabine and Alkylator Therapy
OBJECTIVES: I. Determine the anticancer efficacy of 506U78 in patients with chronic
lymphocytic leukemia refractory to fludarabine and alkylator therapy. II. Determine the
safety (including incidence of infection) of this drug in these patients. III. Evaluate the
pharmacokinetics of 506U78 and ara-G, and assess the intracellular pharmacokinetics of
ara-GTP in patients receiving multiple treatment courses (at M.D. Anderson Cancer Center
only). IV. Determine the response rate, time to maximal response, and duration of response
in patients treated with this drug. V. Determine two-year survival and progression-free
survival of patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to cellular type of
disease (B cell vs T cell). Patients receive 506U78 IV over 2 hours on days 1, 3, and 5.
Treatment repeats every 28 days for a maximum of 8 courses in the absence of disease
progression or unacceptable toxicity. Patients are followed at 28 days and then every 2
months for 2 years until disease progression. After disease progression, patients are
followed every 3 months for 2 years.
PROJECTED ACCRUAL: Approximately 14-100 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
Tonya M. Peele, MS
Study Chair
GlaxoSmithKline
United States: Federal Government
CDR0000066719
NCT00003635
January 1999
Name | Location |
---|---|
Arizona Cancer Center | Tucson, Arizona 85724 |
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Johns Hopkins Oncology Center | Baltimore, Maryland 21287 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
Holden Comprehensive Cancer Center at The University of Iowa | Iowa City, Iowa 52242-1009 |
Lombardi Cancer Center | Washington, District of Columbia 20007 |
Cedars-Sinai Medical Center | Los Angeles, California 90048 |
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Scripps Clinic | La Jolla, California 92037 |
St. Joseph's Hospital and Medical Center | Paterson, New Jersey 07503 |
Sidney Kimmel Cancer Center | San Diego, California 92121 |
Greenville Hospital System | Greenville, South Carolina 29605 |
Long Island Jewish Medical Center | New Hyde Park, New York 11040 |
Medicine Branch | Bethesda, Maryland 20892 |
Clinical Studies, Ltd. | Denver, Colorado 80222 |
Physician Reliance Network, Inc. | Dallas, Texas 75246 |