Vaccine Therapy in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia

Phase 2

Terminated

• Conditions: Leukemia

• Registration Number: NCT00428077
• Lead Sponsor: OHSU Knight Cancer Institute

Brief 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.

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2007-01-25
• Study First Submitted QC: 2007-01-25
• Study First Posted: 2007-01-29
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Results First Submitted: 2011-05-26
• Status Verified: 2011-08
• Results First Submitted QC: 2011-08-01
• Results First Posted: 2011-08-31
• Last Update Submitted: 2011-08-31
• Last Update Posted: 2011-09-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.	Every 3 months for the duration of 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.
Percentage of Patients Who Become RT-PCR-negative for BCR-ABL Transcripts	12-24 Months
Comparison of Response in Patients With B3A2 Junctions vs B2A2 Junctions	12-24 Months
Immunologic Response Over 1 Year	12 months
Correlation of Response With Specific HLA Types	12-24 Months

Secondary Outcome Measures

Name	Time	Method
Safety of a Vaccine Containing Native and Synthetic Chronic Myeloid Leukemia (CML) Peptides Over 1 Year Treatment.	Weeks 2, 4, 6, 9, and monthly thereafter up to 2 years.

Trial Locations

Locations (1)

OHSU Knight Cancer Institute; 🇺🇸 Portland, Oregon, United States