NCT00428077

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	bcr-abl peptide vaccine	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.
GENETIC	reverse transcriptase-polymerase chain reaction	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.

Timeline

• Start date: 2005-10-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2007-01-29
• Last updated: 2011-09-02
• Results posted: 2011-08-31

Locations

1 site across 1 country: United States