Leukemia Clinical Trial
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
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.
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.
;
Primary Purpose: Treatment
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