CMA-676 in Treating Older Patients With Acute Myeloid Leukemia in First Relapse
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of CMA-676 in treating older patients who have acute myeloid leukemia that has recurred for the first time following at least 3 months of complete remission.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Study of the Safety of CMA-676 in Treatment of Elderly Patients With Acute Myeloid Leukemia (AML) in First Relapse|
|Study Start Date:||March 1998|
|Study Completion Date:||March 1999|
|Primary Completion Date:||March 1999 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Assess the efficacy of CMA-676 in elderly patients with acute myeloid leukemia in first relapse in terms of the number of patients attaining a complete remission. II. Assess the safety of CMA-676 in this patient population.
OUTLINE: This is an open label, single arm, multicenter study. Patients receive 1 course of CMA-676 IV over 2 hours on day 1 followed by a 6 hour observation period. Patients may receive 1 additional course of therapy 15 to 28 days later. There is a 28 day follow-up period after the last dose of study medication. Patients are followed for an additional 6 months, then every 3 months for 18 months, and then every 6 months until relapse and/or death.
PROJECTED ACCRUAL: A total of 23-55 patients will be accrued for this study within 12 months. Enrollment will then be extended for up to an additional 55 patients.
|United States, Arizona|
|Arizona Cancer Center|
|Tucson, Arizona, United States, 85724|
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-1781|
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University|
|Chicago, Illinois, United States, 60611|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637|
|United States, Massachusetts|
|New England Medical Center Hospital|
|Boston, Massachusetts, United States, 02111|
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|United States, New York|
|Long Island Jewish Medical Center|
|New Hyde Park, New York, United States, 11040|
|New York Presbyterian Hospital - Cornell Campus|
|New York, New York, United States, 10021|
|State University of New York Health Sciences Center - Stony Brook|
|Stony Brook, New York, United States, 11790-9832|
|United States, Pennsylvania|
|University of Pennsylvania Cancer Center|
|Philadelphia, Pennsylvania, United States, 19104|
|Study Chair:||Mark Stanley Berger, MD||Wyeth is now a wholly owned subsidiary of Pfizer|