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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
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.
OHSU Knight Cancer Institute
Portland, Oregon, United States
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.
Time frame: Every 3 months for the duration of the 1-year treatment period. .
Percentage of Patients Who Become RT-PCR-negative for BCR-ABL Transcripts
Time frame: 12-24 Months
Comparison of Response in Patients With B3A2 Junctions vs B2A2 Junctions
Time frame: 12-24 Months
Immunologic Response Over 1 Year
Time frame: 12 months
Correlation of Response With Specific HLA Types
Time frame: 12-24 Months
Safety of a Vaccine Containing Native and Synthetic Chronic Myeloid Leukemia (CML) Peptides Over 1 Year Treatment.
Time frame: Weeks 2, 4, 6, 9, and monthly thereafter up to 2 years.
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