PHASE II CLINICAL EVALUATION OF BRYOSTATIN 1 IN PATIENTS WITH RELAPSED NON-HODGKIN'S LYMPHOMA AND CLL
OBJECTIVES: I. Assess the efficacy of bryostatin 1 administered as a 72-hour infusion in
patients with relapsed non-Hodgkin's lymphoma and chronic lymphocytic leukemia. II. Gain
information regarding the toxicity and tolerability of escalated vincristine doses given
after each bryostatin 1 infusion in cohorts of patients who fail to respond to bryostatin
alone. III. Determine the qualitative and quantitative toxic effects of bryostatin 1 in
these patients. IV. Determine the duration of response and survival following treatment with
OUTLINE: All patients receive bryostatin 1 by 72-hour continuous infusion every 2 weeks
until disease progression or until 2 courses beyond documentation of complete remission.
Response is assessed after every 4 courses. Patients with disease progression who continue
to meet the eligibility criteria receive vincristine within 2 hours after completion of each
bryostatin 1 infusion. Groups of 3-6 patients receive escalated doses of vincristine until
the maximum tolerated dose with bryostatin 1 is determined. Courses repeat every 2 weeks, as
above; no individual dose escalation is allowed. No concurrent steroids are permitted.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 25 evaluable patients with low-grade NHL or CLL will be
entered over approximately 20 months if there are 2-4 responses in the first 15 patients. A
total of 20 evaluable patients with intermediate- or high-grade NHL will be entered over
approximately 2 years if there are 1 or 2 responses in the first 10 patients.
Primary Purpose: Treatment
Ayad M. Al-Katib, MD, FACP
Barbara Ann Karmanos Cancer Institute
United States: Federal Government
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|