Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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