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Sponsored by: |
Vaccine Company |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00454168 |
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.
Condition | Intervention | Phase |
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Leukemia |
Biological: PR1 leukemia peptide vaccine Biological: sargramostim Other: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Placebo Control |
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 |
Estimated Enrollment: | 244 |
Study Start Date: | May 2005 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive PR1 leukemia peptide vaccine and sargramostim (GM-CSF) subcutaneously.
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Biological: PR1 leukemia peptide vaccine
Given subcutaneously
Biological: sargramostim
Given subcutaneously
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Arm II: Active Comparator
Patients receive placebo vaccine and GM-CSF subcutaneously.
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Biological: sargramostim
Given subcutaneously
Other: placebo
Given subcutaneously
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OBJECTIVES:
Primary
Secondary
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.
PROJECTED ACCRUAL: A total of 244 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of acute myeloid leukemia (AML), defined by the presence of > 20% blasts in marrow or blood, including the following subtypes:
Secondary AML, defined as the following:
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
Marrow blast count < 5% (≤ 200 nucleated cell count)
PATIENT CHARACTERISTICS:
No progressive viral or bacterial infection
PRIOR CONCURRENT THERAPY:
More than 28 days since prior chronic use (> 2 weeks) of corticosteroids > 10 mg/day (prednisone [or equivalent])
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 | |
Vaccine Company | |
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 | |
Cancer Care Centers of South Texas - Southeast | |
San Antonio, Texas, United States, 78222 | |
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | |
Dallas, Texas, United States, 75390 |
Study Chair: | Craig S. Rosenfeld, MD | Vaccine Company |
Responsible Party: | Vaccine Company ( Regulatory Protocol Associate ) |
Study ID Numbers: | CDR0000510853, VACCINE-PR1-104, UCCRC-14613B |
Study First Received: | March 27, 2007 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00454168 History of Changes |
Health Authority: | United States: Food and Drug Administration |
adult acute minimally differentiated myeloid leukemia (M0) adult acute myeloblastic leukemia with maturation (M2) adult acute myeloblastic leukemia without maturation (M1) adult acute myeloid leukemia in remission adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) |
adult acute myelomonocytic leukemia (M4) adult acute promyelocytic leukemia (M3) secondary acute myeloid leukemia adult acute monoblastic leukemia (M5a) adult acute monocytic leukemia (M5b) adult erythroleukemia (M6a) adult pure erythroid leukemia (M6b) adult acute megakaryoblastic leukemia (M7) |
Leukemia, Monocytic, Acute Adjuvants, Immunologic Acute Myelomonocytic Leukemia Acute Monoblastic Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia, Myelomonocytic, Acute Leukemia Acute Myelocytic Leukemia |
Acute Erythroblastic Leukemia Leukemia, Erythroblastic, Acute Acute Myeloid Leukemia, Adult Neoplasm Metastasis Leukemia, Promyelocytic, Acute Congenital Abnormalities Acute Promyelocytic Leukemia Di Guglielmo's Syndrome |
Leukemia Neoplasms Neoplasms by Histologic Type Leukemia, Myeloid Leukemia, Myeloid, Acute |