Lymphoma Clinical Trial
Official title:
Phase I Study of Bryostatin 1 (NSC 339555) and Fludarabine in Patients With Chronic Lymphocytic Leukemia and Indolent Non-Hodgkin's Lymphoma
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of bryostatin 1 plus fludarabine in
treating patients who have chronic lymphocytic leukemia or relapsed, indolent non-Hodgkin's
lymphoma.
OBJECTIVES:
- Determine the toxic effects and maximum tolerated dose of bryostatin 1 and fludarabine
in patients with symptomatic or advanced chronic lymphocytic leukemia or relapsed
indolent non-Hodgkin's lymphoma.
- Monitor apoptosis, differentiation, and protein kinase C activity in leukemic
lymphocytes exposed in vivo to bryostatin 1 and fludarabine.
- Observe the antitumor activity of this combination therapy in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients are assigned to one of two
treatment groups.
- Group I: Patients receive bryostatin 1 IV over 24 hours followed by fludarabine IV over
30 minutes daily on days 1-5.
- Group II: Patients receive fludarabine IV over 30 minutes daily on days 1-5 followed by
bryostatin 1 IV over 24 hours.
In both groups, courses repeat every 4 weeks for patients with stable or responding disease.
Cohorts of 3-6 patients receive escalating doses of fludarabine and bryostatin 1 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. Once the MTD for fludarabine is
determined, the dose of bryostatin 1 is escalated.
PROJECTED ACCRUAL: Approximately 30-60 patients will be accrued for this study within 3
years.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
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