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A Multicenter Study to Assess the Efficacy of 506U78 in Patients With Chronic Lymphocytic Leukemia Who Are Refractory to Fludarabine and Alkylator Therapy (NCT00003635)

National Cancer Institute (NCI)
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.
  • Drug: nelarabine
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    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.

    22 locations

    United States (22)
    • University of Alabama at Birmingham Comprehensive Cancer Center
      Birmingham, Alabama, United States, 35294-3300
    • Arizona Cancer Center
      Tucson, Arizona, United States, 85724
    • University of Arkansas for Medical Sciences
      Little Rock, Arkansas, United States, 72205
    • Scripps Clinic
      La Jolla, California, United States, 92037
    • Cedars-Sinai Medical Center
      Los Angeles, California, United States, 90048
    • Jonsson Comprehensive Cancer Center, UCLA
      Los Angeles, California, United States, 90095-1781
    • Sidney Kimmel Cancer Center
      San Diego, California, United States, 92121
    • Clinical Studies, Ltd.
      Denver, Colorado, United States, 80222
    • Lombardi Cancer Center
      Washington, District of Columbia, United States, 20007
    • Walter Reed Army Medical Center
      Washington, District of Columbia, United States, 20307-5000
    • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
      Chicago, Illinois, United States, 60611-3013
    • University of Chicago Cancer Research Center
      Chicago, Illinois, United States, 60637-1470
    • Holden Comprehensive Cancer Center at The University of Iowa
      Iowa City, Iowa, United States, 52242-1009
    • Johns Hopkins Oncology Center
      Baltimore, Maryland, United States, 21231-2410
    • Medicine Branch
      Bethesda, Maryland, United States, 20892
    • Washington University School of Medicine
      Saint Louis, Missouri, United States, 63110
    • St. Joseph's Hospital and Medical Center
      Paterson, New Jersey, United States, 07503
    • Long Island Jewish Medical Center
      New Hyde Park, New York, United States, 11040
    • Ireland Cancer Center
      Cleveland, Ohio, United States, 44106-5065
    • Greenville Hospital System
      Greenville, South Carolina, United States, 29605
    • Physician Reliance Network, Inc.
      Dallas, Texas, United States, 75246
    • University of Texas - MD Anderson Cancer Center
      Houston, Texas, United States, 77030-4009
    Status:
    completed
    Type:
    Interventional
    Phase:
    Start:
    31 December, 1998
    Updated:
    16 July, 2013
    Participants:
    0
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