Vaccine Therapy in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia
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|ClinicalTrials.gov Identifier: NCT00428077|
Recruitment Status : Terminated (Withdrawn because there were no dramatic changes in the main endpoint, as well as low enrollment numbers. The data are not interpretable in terms of efficacy.)
First Posted : January 29, 2007
Results First Posted : August 31, 2011
Last Update Posted : September 2, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Biological: bcr-abl peptide vaccine Genetic: reverse transcriptase-polymerase chain reaction||Phase 2|
- 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 (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2005|
|Primary Completion Date :||April 2009|
|Study Completion Date :||April 2009|
Biological: bcr-abl peptide vaccine
- 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00428077
|United States, Oregon|
|OHSU Knight Cancer Institute|
|Portland, Oregon, United States, 97239-3098|
|Study Chair:||Michael Deininger, MD, PhD||OHSU Knight Cancer Institute|