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PURPOSE: Phase II trial to study the effectiveness of combining bryostatin 1 with cytarabine in treating patients who have relapsed primary acute myelogenous leukemia.
- Determine the response rate in patients with primary acute myelogenous leukemia in first relapse treated with bryostatin 1 and high-dose cytarabine.
- Determine the toxic effects of this regimen in these patients.
- Determine the relapse-free survival and overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
- Induction: Patients receive bryostatin 1 IV over 24 hours on days 1 and 11. Patients also receive high-dose cytarabine IV over 3 hours every 12 hours for 4 infusions on days 2-3 and days 9-10.
Patients who achieve a major response receive a second course of induction therapy.
- Consolidation: Patients who achieve complete remission receive bryostatin 1 IV over 24 hours on days 1 and 10 and high-dose cytarabine IV over 3 hours every 12 hours for 2 infusions on days 2 and 9. Treatment continues for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients who achieve a response and subsequently relapse may receive additional induction and consolidation therapy at the discretion of the investigator.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 15-46 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
bryostatin 1, cytarabine
Herbert Irving Comprehensive Cancer Center at Columbia University
Virginia Commonwealth University
Published on BioPortfolio: 2014-07-24T14:35:02-0400
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