Vaccine Therapy in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia
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.
|Leukemia||Biological: bcr-abl peptide vaccine Genetic: reverse transcriptase-polymerase chain reaction||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- 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. [ Time Frame: 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 [ 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. ]
|Study Start Date:||October 2005|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Biological: bcr-abl peptide vaccine
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00428077
|United States, Oregon|
|OHSU Knight Cancer Institute|
|Portland, Oregon, United States, 97239-3098|
|Study Chair:||Michael Deininger, MD, PhD||OHSU Knight Cancer Institute|