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PURPOSE: 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.
OBJECTIVES: I. Determine the maximum tolerated dose of bryostatin 1 when combined with vincristine in patients with B-cell malignancies. II. Assess clinical responses in patients treated with this regimen.
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.
PROJECTED ACCRUAL: Approximately 18 patients will be accrued for this study within 12-15 months.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
bryostatin 1, vincristine sulfate
Ireland Cancer Center at University Hospitals Case Medical Center
Case Comprehensive Cancer Center
Published on BioPortfolio: 2014-08-27T03:58:48-0400
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Derivatives of chondroitin which have a sulfate moiety esterified to the galactosamine moiety of chondroitin. Chondroitin sulfate A, or chondroitin 4-sulfate, and chondroitin sulfate C, or chondroitin 6-sulfate, have the sulfate esterified in the 4- and 6-positions, respectively. Chondroitin sulfate B (beta heparin; DERMATAN SULFATE) is a misnomer and this compound is not a true chondroitin sulfate.
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An enzyme that specifically cleaves the ester sulfate of iduronic acid. Its deficiency has been demonstrated in Hunter's syndrome, which is characterized by an excess of dermatan sulfate and heparan sulfate. EC 188.8.131.52.
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