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.
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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
55
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
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