RATIONALE: Vaccines made from peptides that are found on leukemia cells may make the body build an immune response and kill cancer cells. Combining vaccine therapy with the immune adjuvant Montanide ISA-51 may be a more effective treatment for chronic myeloid leukemia, acute myeloid leukemia, or myelodysplastic syndrome.

PURPOSE: This phase I/II trial is studying the side effects and best dose of vaccine therapy when given with Montanide ISA-51 and to see how well they work in treating patients with chronic myeloid leukemia, acute myeloid leukemia, or myelodysplastic syndrome.

Condition	Treatment or Intervention	Phase
adult acute myeloid leukemia atypical chronic myeloid leukemia childhood acute myeloid leukemia and other myeloid malignancies Chronic Myelogenous Leukemia myelodysplastic and myeloproliferative disease	Drug: Montanide ISA-51  Drug: PR1 leukemia peptide vaccine  Drug: sargramostim  Procedure: biological response modifier therapy  Procedure: colony-stimulating factor therapy  Procedure: cytokine therapy  Procedure: non-specific immune-modulator therapy  Procedure: non-tumor cell derivative vaccine  Procedure: vaccine therapy	Phase I Phase II

Further Study Details: 

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 9 weeks, for a total of 3 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 or immune reaction to the vaccine are followed 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

Texas
      MD Anderson Cancer Center at University of Texas, Houston,  Texas,  77030-1402,  United States; Recruiting

Study chairs or principal investigators

Muzaffar H. Qazilbash, MD,  Study Chair,  M.D. Anderson Cancer Center   
Richard E. Champlin, MD,  M.D. Anderson Cancer Center   

Study ID Numbers:  CDR0000067600; MDA-DM-97325; NCI-T98-0017; NCT00004918
Record last reviewed:  June 2004
Last Updated:  February 7, 2005
Record first received:  March 7, 2000
ClinicalTrials.gov Identifier:  NCT00004918
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08