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PURPOSE: This phase I/II trial is studying the side effects and best dose of oblimersen and to see how well it works in treating patients with relapsed or refractory Waldenstrom's macroglobulinemia.
- Determine the maximum tolerated dose and recommended phase II dose of oblimersen in patients with relapsed or refractory Waldenstrom's macroglobulinemia.
- Determine the response rate and duration of response in patients treated with this drug.
- Determine the safety of this drug in these patients.
- Determine the survival of patients treated with this drug.
- Determine the use of epoetin alfa in patients treated with this drug.
- Determine the clinical benefit of this drug, in terms of improvement in hemoglobin (greater than 11 g/dL) and platelet count (greater than 100,000/mm^3), in these patients.
OUTLINE: This is a multicenter, dose-escalation study.
- Phase I: Patients receive oblimersen IV continuously on days 1-7. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 1-6 patients receive escalating doses of oblimersen until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
- Phase II: Patients receive treatment as in phase I at the MTD of oblimersen. Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: A maximum of 61 patients will be accrued for this study within approximately 3.2 years.
Primary Purpose: Treatment
Mayo Clinic Scottsdale
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-07-24T14:33:43-0400
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