Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia in Remission

NCT00454168 | Unknown Phase 3

• 3 other identifiers: CDR0000510853VACCINE-PR1-104UCCRC-14613B
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 15

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.

Conditions

Leukemia

Keywords

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)

Outcome Measures

Primary Outcomes (1)

• Overall survival

Secondary Outcomes (3)

• Relapse-free survival

• Remission duration

• Immune response as measured by PR1-HLA-A2 tetramer assay

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive PR1 leukemia peptide vaccine and sargramostim (GM-CSF) subcutaneously.

Biological: PR1 leukemia peptide vaccine; Biological: sargramostim

Arm II

ACTIVE COMPARATOR

Patients receive placebo vaccine and GM-CSF subcutaneously.

Biological: sargramostim; Other: placebo

Interventions

PR1 leukemia peptide vaccine BIOLOGICAL

Given subcutaneously

Arm I

sargramostim BIOLOGICAL

Given subcutaneously

Arm I; Arm II

placebo OTHER

Given subcutaneously

Arm II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• The Vaccine Company: lead

Study Sites (15)

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259-5499, United States

Location

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

Vaccine Company

South San Francisco, California, 94080, United States

Location

Rush Cancer Institute at Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

St. Francis Hospital Cancer Care Services

Indianapolis, Indiana, 46237, United States

Location

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Kansas City, Kansas, 66160-7357, United States

Location

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

UPMC Cancer Centers

Pittsburgh, Pennsylvania, 15232, United States

Location

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390, United States

Location

Cancer Care Centers of South Texas - Southeast

San Antonio, Texas, 78222, United States

Location

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid, Acute; Congenital Abnormalities; Leukemia, Myelomonocytic, Acute; Leukemia, Promyelocytic, Acute; Leukemia, Monocytic, Acute; Leukemia, Erythroblastic, Acute; Leukemia, Megakaryoblastic, Acute

Interventions

sargramostim

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Myeloproliferative Disorders; Bone Marrow Diseases

Study Officials

• Craig S. Rosenfeld, MD

  The Vaccine Company

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 27, 2007
• First Posted: March 30, 2007
• Study Start: May 1, 2005
• Primary Completion: April 1, 2009
• Last Updated: January 6, 2014

Record last verified: 2009-02

Locations

US (15)