RATIONALE: Vaccines made from a peptide may help the body build an effective immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, increase the number of white blood cells and platelets found in bone marrow or peripheral blood. Giving vaccine therapy together with GM-CSF may be an effective treatment for acute myeloid leukemia. It is not yet known whether giving vaccine therapy together with GM-CSF is more effective than giving placebo together with GM-CSF in treating acute myeloid leukemia. PURPOSE: This randomized phase III trial is studying vaccine therapy and GM-CSF to see how well they work compared with a placebo and GM-CSF in treating patients with acute myeloid leukemia in remission.
OBJECTIVES: Primary * Compare improvement of overall survival of patients with acute myeloid leukemia treated with PR1 leukemia peptide vaccine and sargramostim (GM-CSF) vs placebo vaccine and GM-CSF. Secondary * Compare improvement of relapse-free survival of patients treated with these regimens. * Compare remission duration in patients treated with these regimens. * Compare immune response, as measured by PR1-HLA-A2 tetramer assay, in patients treated with these regimens. OUTLINE: This is a randomized, placebo-controlled, multicenter study. Patients are stratified according to age and complete remission (CR) (≥ 18 years of age and in second CR vs ≥ 55 years of age and in first CR), type of acute myeloid leukemia (de novo vs secondary), and cytogenetics (unfavorable vs favorable and intermediate). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive PR1 leukemia peptide vaccine and sargramostim (GM-CSF) subcutaneously (SC). * Arm II: Patients receive placebo vaccine and GM-CSF SC. PROJECTED ACCRUAL: A total of 244 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Enrollment
244
Given subcutaneously
Given subcutaneously
Given subcutaneously
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States
Vaccine Company
South San Francisco, California, United States
Rush Cancer Institute at Rush University Medical Center
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
St. Francis Hospital Cancer Care Services
Indianapolis, Indiana, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
...and 5 more locations
Overall survival
Relapse-free survival
Remission duration
Immune response as measured by PR1-HLA-A2 tetramer assay
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