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

Inclusion 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