Spots Global Cancer Trial Database for Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia in Remission
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Trial Identification
Brief Title: Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia in Remission
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
Study ID: NCT00454168
Conditions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Case Comprehensive Cancer Center, Cleveland, Ohio, United States
UPMC Cancer Centers, Pittsburgh, Pennsylvania, United States
Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, United States
Cancer Care Centers of South Texas - Southeast, San Antonio, Texas, United States
Contact Details
Name: Craig S. Rosenfeld, MD
Affiliation: The Vaccine Company
Role: STUDY_CHAIR
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