Bryostatin 1 and Cytarabine in Treating Patients With Relapsed Acute Myelogenous Leukemia
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.
|Study Design:||Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Study Of Bryostatin 1 (NSC 339555) And High-Dose 1-B-D-Arabinofuranosylcytosine (HiDAC) In Patients With Refractory Leukemia|
|Study Start Date:||July 2001|
|Study Completion Date:||June 2005|
|Primary Completion Date:||September 2004 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00017342
|United States, New York|
|New York Weill Cornell Cancer Center at Cornell University|
|New York, New York, United States, 10021|
|Herbert Irving Comprehensive Cancer Center at Columbia University|
|New York, New York, United States, 10032|
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|United States, Virginia|
|Massey Cancer Center at Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298-0037|
|Study Chair:||Steven Grant, MD||Massey Cancer Center|