Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia in Remission
Recruitment status was: Active, not recruiting
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.
Biological: PR1 leukemia peptide vaccine
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Phase 3, Randomized, Double-Blind, Multicenter Study of Proteinase 3 PR1 Peptide Mixed With Montanide ISA-51 VG Adjuvant and Administered With GM-CSF in Elderly Patients With AML in First Complete Remission or Adults in Second Complete Remission: A Pivotal Study|
- Overall survival [ Designated as safety issue: No ]
- Relapse-free survival [ Designated as safety issue: No ]
- Remission duration [ Designated as safety issue: No ]
- Immune response as measured by PR1-HLA-A2 tetramer assay [ Designated as safety issue: No ]
|Study Start Date:||May 2005|
|Estimated Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive PR1 leukemia peptide vaccine and sargramostim (GM-CSF) subcutaneously.
Biological: PR1 leukemia peptide vaccine
Given subcutaneouslyBiological: sargramostim
Active Comparator: Arm II
Patients receive placebo vaccine and GM-CSF subcutaneously.
Given subcutaneouslyOther: placebo
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00454168
|United States, Arizona|
|Mayo Clinic Scottsdale|
|Scottsdale, Arizona, United States, 85259-5499|
|United States, California|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095-1781|
|South San Francisco, California, United States, 94080|
|United States, Illinois|
|Rush Cancer Institute at Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|United States, Indiana|
|Indiana University Melvin and Bren Simon Cancer Center|
|Indianapolis, Indiana, United States, 46202-5289|
|St. Francis Hospital Cancer Care Services|
|Indianapolis, Indiana, United States, 46237|
|United States, Kansas|
|Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160-7357|
|United States, Maryland|
|Greenebaum Cancer Center at University of Maryland Medical Center|
|Baltimore, Maryland, United States, 21201|
|United States, North Carolina|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599-7295|
|United States, Ohio|
|Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|United States, Pennsylvania|
|UPMC Cancer Centers|
|Pittsburgh, Pennsylvania, United States, 15232|
|United States, South Carolina|
|Hollings Cancer Center at Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|United States, Texas|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas|
|Dallas, Texas, United States, 75390|
|Cancer Care Centers of South Texas - Southeast|
|San Antonio, Texas, United States, 78222|
|Study Chair:||Craig S. Rosenfeld, MD||The Vaccine Company|