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Phase II Study Of Bryostatin 1 (NSC 339555) And High-Dose 1-B-D-Arabinofuranosylcytosine (HiDAC) In Patients With Refractory 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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
July 1, 2001
Primary Completion Date
September 1, 2004
Completion Date
June 1, 2005
Last Updated
March 1, 2010
bryostatin 1
DRUG
cytarabine
DRUG
Lead Sponsor
Virginia Commonwealth University
Collaborators
NCT06311227
NCT06285890
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT00106925