Bryostatin 1 in Treating Patients With Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
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: Phase I/II trial to study the effectiveness of bryostatin 1 in treating patients who have relapsed non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||PHASE II CLINICAL EVALUATION OF BRYOSTATIN 1 IN PATIENTS WITH RELAPSED NON-HODGKIN'S LYMPHOMA AND CLL|
|Study Start Date:||December 1996|
|Study Completion Date:||November 2001|
|Primary Completion Date:||February 2000 (Final data collection date for primary outcome measure)|
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 bryostatin 1.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002908
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|Study Chair:||Ayad M. Al-Katib, MD, FACP||Barbara Ann Karmanos Cancer Institute|