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A Phase I Trial of Combination Bryostatin 1 (NSC 339555) and Vincristine in B-Cell Malignancies
This phase I trial is studying the side effects and best dose of bryostatin-1 when given together with vincristine in treating patients with chronic lymphocytic leukemia, non-Hodgkin's lymphoma, or multiple myeloma. 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
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose of bryostatin 1 as a 24 hour infusion and vincristine when administered sequentially. II. To determine the effect of this combination on programmed cell death (apoptosis). III. To determine the immunomodulatory effect of bryostatin 1. IV. To observe patients for clinical antitumor response after giving combination bryostatin 1 and vincristine. OUTLINE: This is a dose-escalation study of bryostatin 1. Patients receive bryostatin 1 IV over 24 hours followed immediately by vincristine IV. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients completing 6 courses of therapy may receive subsequent courses every 3 weeks and then every 4 weeks after 24 months of treatment. Patients may return to a 2- or 3-week treatment course at the discretion of the principal investigator. Cohorts of 3 patients receive escalating doses of bryostatin 1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 1 of 3 patients experience dose-limiting toxicity. Patients are followed every 3 months.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Case Western Reserve University
Cleveland, Ohio, United States
Start Date
May 1, 1998
Primary Completion Date
July 1, 2001
Last Updated
January 11, 2013
18
ESTIMATED participants
bryostatin 1
DRUG
vincristine sulfate
DRUG
laboratory biomarker analysis
OTHER
Lead Sponsor
National Cancer Institute (NCI)
NCT02153580
NCT01815749
Data Source & Attribution
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