Vaccine Therapy in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia

A Multi-Center Pilot Phase II Trial of a Synthetic Tumor-Specific Breakpoint Peptide Vaccine in Patients With Chronic Myeloid Leukemia (CML) and Minimal Residual Disease

Withdrawn because there were no dramatic changes in the main endpoint, as well as low enrollment numbers. The data are not interpretable in terms of efficacy.

RATIONALE: Vaccines made from a peptide may help the body build an effective immune response to kill cancer cells. PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with chronic phase chronic myelogenous leukemia.

OBJECTIVES: Determine the antileukemic effects of tumor-specific Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL) junction specific peptide vaccine, as measured by a decrease in circulating BCR-ABL transcripts by reverse-transcriptase polymerase chain reaction (RT-PCR), that persist for at least 3 months, in patients with chronic phase chronic myelogenous leukemia. Determine the percentage of patients treated with this vaccine who become RT-PCR-negative for BCR-ABL transcripts. Compare response in patients with B3A2 junctions vs B2A2 junctions when treated with this vaccine. Determine the immunologic response over 1 year in patients treated with this vaccine. Correlate response with specific HLA types in these patients. Determine the safety of this vaccine in these patients. OUTLINE: This is a pilot, multicenter study. Patients receive BCR-ABL junction-specific peptide vaccine subcutaneously in weeks 2, 4, 6, 8, and 11 and then once monthly for 10 months. BCR-ABL transcript levels are assessed by quantitative reverse-transcriptase polymerase chain reaction at baseline, weeks 2, 4, and 6, every 3 months during treatment, and then 2 weeks after completion of study treatment. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia

Patients will be vaccinated 15 times over 12 months with a vaccine comprised of native and synthetic break-point cluster region-Abelson murine leukemia(BCR-ABL) specific peptides and the immunologic adjuvants, Montanide ISA 51-VG.

A "baseline" reverse transcriptase-polymerase chain reaction(RT-PCR) transcript level of BCR-ABL will be determined after enrollment on study. This baseline will be used to measure response to the vaccine. Patients will have 3 quantitative RT-PCR tests for BCR-ABL transcript levels performed on their peripheral blood in the first month after enrolling on study. Peripheral blood samples will be drawn at approximately 1-month prior (about day -30), 2 weeks prior (about day -14), and the day of the first vaccination (day 0). Samples will be analyzed at a central lab and the three values will be averaged to determine a "baseline" circulating transcript level. During this one-month period, a peripheral blood sample will be analyzed to determine whether patients have a B3A2 or B2A2 junction.

Number of Participants With One-log Decrease in Circulation Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL) Transcripts That Persists for at Least Three Months During the 1-year Treatment Period.

One-log decrease in circulating BCR-ABL transcripts (RT-PCR) that persists for at least three months during the 1-year treatment period.

Safety of a Vaccine Containing Native and Synthetic Chronic Myeloid Leukemia (CML) Peptides Over 1 Year Treatment.

DISEASE CHARACTERISTICS: Diagnosis of Philadelphia chromosome-positive or BCR-ABL-positive chronic phase chronic myelogenous leukemia (CML) In complete cytogenetic remission confirmed by 2 bone marrows ≥ 1 month apart Minimal residual disease Detectable BCR-ABL transcript levels obtained < 6 months apart AND ≤ 0.5-log lower than the lowest value obtained within the past 6 months PATIENT CHARACTERISTICS: Karnofsky performance status 80-100% Bilirubin < 2 times upper limit of normal (ULN) Creatinine < 1.5 times ULN ALT and AST < 2.5 times ULN PRIOR CONCURRENT THERAPY: Recovered from prior therapy No major surgery within the past 4 weeks No prior chemotherapy No prior immunosuppressive therapy No prior corticosteroids No prior stem cell transplantation No radiotherapy within the past 4 weeks No other concurrent investigational agents