Spots Global Cancer Trial Database for Bryostatin 1 and Cytarabine in Treating Patients With Relapsed Acute Myelogenous Leukemia
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Trial Identification
Brief Title: Bryostatin 1 and Cytarabine in Treating Patients With Relapsed Acute Myelogenous Leukemia
Official Title: Phase II Study Of Bryostatin 1 (NSC 339555) And High-Dose 1-B-D-Arabinofuranosylcytosine (HiDAC) In Patients With Refractory Leukemia
Study ID: NCT00017342
Conditions
Study Description
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Steven Grant, MD
Affiliation: Massey Cancer Center
Role: STUDY_CHAIR
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