• Immune response at 3 weeks after last vaccine [ Designated as safety issue: No ]
  
• Clinical response at 3 weeks after last vaccine [ Designated as safety issue: No ]
  

• Event-free survival as measured by Kaplan-Meier at 1 year [ Designated as safety issue: No ]
  
• Overall survival as measure by Kaplan-Meier at 1 year [ Designated as safety issue: No ]
  

OBJECTIVES:

• Determine the toxicity and immunological activity of PR1 leukemia peptide vaccine administered with Montanide ISA-51 in patients with chronic myeloid leukemia, acute myeloid leukemia, or myelodysplastic syndromes.
• Evaluate possible clinical efficacy of this vaccine in high-risk HLA-A2-positive patients with myeloid leukemias.

OUTLINE: This is a phase I dose-escalation study of PR1 leukemia peptide vaccine, followed by a phase II randomized study.

Patients receive PR1 leukemia peptide vaccine with Montanide ISA-51 (ISA-51) subcutaneously (SC) once every 3 weeks for 18 weeks, for a total of 6 vaccinations. Patients also receive sargramostim (GM-CSF) SC with each vaccination.

Cohorts of 3 patients receive escalating doses of PR1 leukemia peptide vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose-limiting toxicity.

Additional patients are accrued to the phase II portion of the study and are randomized to receive one of three dose levels of PR1 leukemia peptide vaccine with ISA-51. Patients in each of the 3 arms receive treatment as in the phase I portion of the study.

Patients achieving a clinical response and/or clinical response to the vaccine whose disease progresses within 6-12 months after the first set of vaccinations may receive additional vaccine as before.

Patients achieving a clinical response or immune reaction to the vaccine are followed at least monthly until death or until the clinical response and/or immune reaction is lost.

PROJECTED ACCRUAL: A total of 3-9 patients will be accrued for the phase I dose escalation portion of this study. A maximum of 60 patients (20 per arm) will be accrued for the phase II randomized portion of this study.

DISEASE CHARACTERISTICS:

• Diagnosis of chronic myeloid leukemia in chronic phase or early accelerated phase

  • Ineligible for bone marrow transplantation (BMT) or interferon OR
  • Failed standard therapy OR
  • Relapsed after BMT OR

• Diagnosis of 1 of the following diseases and not a candidate for chemotherapy:

  • Myelodysplastic syndromes in second or subsequent remission

    • Refractory anemia with excess blasts (RAEB) OR
    • RAEB in transformation
  • Acute myeloid leukemia (AML) in second or subsequent remission
  • AML with a smoldering presentation
• HLA-A2 positive at one allele

PATIENT CHARACTERISTICS:

Age:

• Over 18

Performance status:

• ECOG 0-2

Life expectancy:

• At least 9 weeks

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin less than 3 mg/dL
• ALT less than 3 times upper limit of normal

Renal:

• Creatinine less than 2 mg/dL

Pulmonary:

• FEV, FVC, and DLCO greater than 50% of predicted
• No symptomatic pulmonary disease

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other concurrent illness that severely limits life expectancy
• No known history of Wegener's granulomatosis or other vasculitis
• No known allergy to Montanide ISA-51
• No active uncontrolled infection
• No serologic antibody against proteinase 3
• HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• See Disease Characteristics
• No concurrent interferon

Chemotherapy:

• See Disease Characteristics
• No concurrent chemotherapy except hydroxyurea to control cell counts

Endocrine therapy:

• At least 1 month since prior steroids
• No concurrent steroids

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• At least 1 month since prior cyclosporine or tacrolimus
• No concurrent cyclosporine or tacrolimus