Bryostatin 1 and Cytarabine in Treating Patients With Relapsed Acute Myelogenous Leukemia
- Conditions
- Leukemia
- Registration Number
- NCT00017342
- Lead Sponsor
- Virginia Commonwealth University
- Brief Summary
RATIONALE: 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.
PURPOSE: Phase II trial to study the effectiveness of combining bryostatin 1 with cytarabine in treating patients who have relapsed primary acute myelogenous leukemia.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
New York Weill Cornell Cancer Center at Cornell University
🇺🇸New York, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
🇺🇸New York, New York, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Massey Cancer Center at Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
New York Weill Cornell Cancer Center at Cornell University🇺🇸New York, New York, United States