Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia in Remission
This trial is active, not recruiting.
|Treatments||pr1 leukemia peptide vaccine, sargramostim, placebo|
|Sponsor||The Vaccine Company|
|Start date||May 2005|
|End date||April 2009|
|Trial size||244 participants|
|Trial identifier||NCT00454168, CDR0000510853, UCCRC-14613B, VACCINE-PR1-104|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Scottsdale, AZ||Mayo Clinic Scottsdale||no longer recruiting|
|Los Angeles, CA||Jonsson Comprehensive Cancer Center at UCLA||no longer recruiting|
|South San Francisco, CA||Vaccine Company||no longer recruiting|
|Chicago, IL||Rush Cancer Institute at Rush University Medical Center||no longer recruiting|
|Chicago, IL||University of Chicago Cancer Research Center||no longer recruiting|
|Indianapolis, IN||Indiana University Melvin and Bren Simon Cancer Center||no longer recruiting|
|Indianapolis, IN||St. Francis Hospital Cancer Care Services||no longer recruiting|
|Kansas City, KS||Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center||no longer recruiting|
|Baltimore, MD||Greenebaum Cancer Center at University of Maryland Medical Center||no longer recruiting|
|Chapel Hill, NC||Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||no longer recruiting|
|Cleveland, OH||Case Comprehensive Cancer Center||no longer recruiting|
|Pittsburgh, PA||UPMC Cancer Centers||no longer recruiting|
|Charleston, SC||Hollings Cancer Center at Medical University of South Carolina||no longer recruiting|
|Dallas, TX||Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas||no longer recruiting|
|San Antonio, TX||Cancer Care Centers of South Texas - Southeast||no longer recruiting|
Immune response as measured by PR1-HLA-A2 tetramer assay
Male or female participants at least 18 years old.
DISEASE CHARACTERISTICS: - Diagnosis of acute myeloid leukemia (AML), defined by the presence of > 20% blasts in marrow or blood, including the following subtypes: - De novo AML, defined as AML with no clinical history of prior myelodysplastic syndromes (MDS) or myeloproliferative disorder (MPD) or exposure to potentially leukemogenic therapies or agents - Secondary AML, defined as the following: - AML secondary to prior existing MDS or MPD or development of AML secondary to proven leukemogenic exposure - History of fatigue, bleeding, or recurrent infections preceding diagnosis of AML by ≥ 1 month with confirmation of existing peripheral blood film that demonstrates morphologic dysplasia - In first complete remission (CR) (patients ≥ 55 years of age) OR second CR (patients ≥ 18 years of age) within the past month - FAB stages M0-M2 and M4-M7 allowed if in first CR - No acute promyelocytic leukemia in first CR - FAB stages M0-M7 allowed if in second CR - Marrow blast count < 5% (≤ 200 nucleated cell count) - No blasts in blood - HLA-A2 positive at 1 allele - No extramedullary disease - No Auer rods - No active meningeal or CNS leukemia PATIENT CHARACTERISTICS: - ECOG performance status 0-1 - Life expectancy must not be severely limited by other diseases - Absolute neutrophil count > 1,000/mm^3 - Platelet count > 100,000/mm^3 - Bilirubin < 2 mg/mL - ALT < 2 times upper limit of normal - Creatinine ≤ 1.6 mg/mL - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Antineutrophil cytoplasmic antibody negative - No serious medical condition, laboratory abnormality, or psychiatric illness that would preclude study compliance or increase risk to patient - No other malignancy within the past 5 years except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast - No known allergy to incomplete Freund's adjuvant - No hypercalcemia - No progressive viral or bacterial infection - Must be afebrile for 7 days without antibiotics - No symptomatic cardiac disease - LVEF ≥ 40% - No symptomatic pulmonary disease - FEV_1, FVC, and DLCO ≥ 50% of predicated (without bronchodilator) - No history of HIV positivity or AIDS - No known hypersensitivity to sargramostim (GM-CSF), yeast-derived products, or any component of this product - No history of Wegener's granulomatosis or vasculitis PRIOR CONCURRENT THERAPY: - Recovered from prior surgery and/or radiotherapy - No prior allogeneic or syngeneic stem cell transplantation - No prior solid organ transplantation - No prior vaccine therapy for AML - More than 28 days since prior chronic use (> 2 weeks) of corticosteroids > 10 mg/day (prednisone [or equivalent]) - Concurrent topical or inhaled corticosteroids allowed - More than 3 months since prior experimental therapy, cyclosporine, or tacrolimus - No concurrent radiotherapy
|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|
|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.|
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