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

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.

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.

Eligibility Criteria:
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