Finding studies
Finding studies
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Lead
Virginia Commonwealth University
With
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted