Spots Global Cancer Trial Database for CMA-676 in Treating Patients With Acute Myeloid Leukemia in First Relapse
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Trial Identification
Brief Title: CMA-676 in Treating Patients With Acute Myeloid Leukemia in First Relapse
Official Title: A Study of the Efficacy and Safety of CMA-676 as Single Agent Treatment of Patients With Acute Myeloid Leukemia (AML) in First Relapse
Study ID: NCT00003131
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 patients with acute myeloid leukemia in first relapse.
Detailed Description: OBJECTIVES: I. Assess the efficacy of CMA-676 in terms of the number of patients with acute myeloid leukemia 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 CMA-676 IV over 2 hours on day 1. Patients may receive 1 additional dose of therapy 15 to 28 days later. Patients who achieve complete or morphologic remission are followed for an additional 6 months and every 3-6 months thereafter until relapse and/or death. PROJECTED ACCRUAL: 55 evaluable patients will be accrued. Enrollment will then be extended for up to an additional 55 patients.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Cancer Center, Tucson, Arizona, United States
Beckman Research Institute, City of Hope, Duarte, California, United States
Sylvester Cancer Center, University of Miami, Miami, Florida, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland, United States
New England Medical Center Hospital, Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
University of Nebraska Medical Center, Omaha, Nebraska, 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
University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, 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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