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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00428077
Study type Interventional
Source OHSU Knight Cancer Institute
Contact
Status Terminated
Phase Phase 2
Start date October 2005
Completion date April 2009

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