Spots Global Cancer Trial Database for CMA-676 in Treating Older Patients With Acute Myeloid Leukemia in First Relapse
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Trial Identification
Brief Title: CMA-676 in Treating Older Patients With Acute Myeloid Leukemia in First Relapse
Official Title: A Study of the Safety of CMA-676 in Treatment of Elderly Patients With Acute Myeloid Leukemia (AML) in First Relapse
Study ID: NCT00003673
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. 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.
Detailed Description: 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.
Eligibility
Minimum Age: 60 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Cancer Center, Tucson, Arizona, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
New England Medical Center Hospital, Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Long Island Jewish Medical Center, New Hyde Park, New York, United States
New York Presbyterian Hospital - Cornell Campus, New York, New York, United States
State University of New York Health Sciences Center - Stony Brook, Stony Brook, New York, United States
University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, United States
Contact Details
Name: Mark Stanley Berger, MD
Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
Role: STUDY_CHAIR
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