Spots Global Cancer Trial Database for 506U78 in Treating Patients With Chronic Lymphocytic Leukemia That Has Not Responded to Fludarabine or Alkylating Agents
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Trial Identification
Brief Title: 506U78 in Treating Patients With Chronic Lymphocytic Leukemia That Has Not Responded to Fludarabine or Alkylating Agents
Official Title: A Multicenter Study to Assess the Efficacy of 506U78 in Patients With Chronic Lymphocytic Leukemia Who Are Refractory to Fludarabine and Alkylator Therapy
Study ID: NCT00003635
Conditions
Interventions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of 506U78 in treating patients with chronic lymphocytic leukemia that has not responded to fludarabine or alkylating agents.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States
Arizona Cancer Center, Tucson, Arizona, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Scripps Clinic, La Jolla, California, United States
Cedars-Sinai Medical Center, Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
Sidney Kimmel Cancer Center, San Diego, California, United States
Clinical Studies, Ltd., Denver, Colorado, United States
Lombardi Cancer Center, Washington, District of Columbia, United States
Walter Reed Army Medical Center, Washington, District of Columbia, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Holden Comprehensive Cancer Center at The University of Iowa, Iowa City, Iowa, United States
Johns Hopkins Oncology Center, Baltimore, Maryland, United States
Medicine Branch, Bethesda, Maryland, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
St. Joseph's Hospital and Medical Center, Paterson, New Jersey, United States
Long Island Jewish Medical Center, New Hyde Park, New York, United States
Ireland Cancer Center, Cleveland, Ohio, United States
Greenville Hospital System, Greenville, South Carolina, United States
Physician Reliance Network, Inc., Dallas, Texas, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
Contact Details
Name: Tonya M. Peele, MS
Affiliation: GlaxoSmithKline
Role: STUDY_CHAIR
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