Leukemia Clinical Trial
Official title:
Phase I Clinical Evaluation of Bryostatin 1 in Combination With 2-CdA in Patients With Relapsed CLL
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of cladribine when
given with bryostatin 1 in treating patients with relapsed chronic lymphocytic leukemia.
OBJECTIVES:
- Determine the maximum tolerated dose of cladribine when administered after bryostatin 1
in patients with relapsed chronic lymphocytic leukemia.
- Determine the qualitative and quantitative toxic effects of this regimen in these
patients.
OUTLINE: This is a multicenter, dose-escalation study of cladribine.
Patients receive bryostatin 1 IV continuously on days 1-3 immediately followed by cladribine
IV continuously on days 4-8. Courses repeat every 4 weeks in the absence of disease
progression or unacceptable toxicity. Patients who achieve complete remission (CR) receive 2
additional courses past CR.
Cohorts of 3-6 patients receive escalating dose levels of cladribine until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 6 patients experience dose-limiting toxicity.
Patients are followed at 3 weeks.
PROJECTED ACCRUAL: A minimum of 15 patients will be accrued for this study.
;
Primary Purpose: Treatment
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