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
18 Years
N/A
Both
Leukemia
Trial Information
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
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of Philadelphia chromosome-positive or BCR-ABL-positive chronic phase
chronic myelogenous leukemia (CML)
- In complete cytogenetic remission confirmed by 2 bone marrows ≥ 1 month apart
- Minimal residual disease
- Detectable BCR-ABL transcript levels obtained < 6 months apart AND ≤ 0.5-log lower
than the lowest value obtained within the past 6 months
PATIENT CHARACTERISTICS:
- Karnofsky performance status 80-100%
- Bilirubin < 2 times upper limit of normal (ULN)
- Creatinine < 1.5 times ULN
- ALT and AST < 2.5 times ULN
PRIOR CONCURRENT THERAPY:
- Recovered from prior therapy
- No major surgery within the past 4 weeks
- No prior chemotherapy
- No prior immunosuppressive therapy
- No prior corticosteroids
- No prior stem cell transplantation
- No radiotherapy within the past 4 weeks
- No other concurrent investigational agents
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Description:
One-log decrease in circulating BCR-ABL transcripts (RT-PCR) that persists for at least three months during the 1-year treatment period.
Outcome Time Frame:
Every 3 months for the duration of the 1-year treatment period. .
Safety Issue:
No
Principal Investigator
Michael Deininger, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
OHSU Knight Cancer Institute
Authority:
United States: Federal Government
Study ID:
CDR0000526322
NCT ID:
NCT00428077
Start Date:
October 2005
Completion Date:
April 2009
Related Keywords:
- Leukemia
- Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia
- chronic phase chronic myelogenous leukemia
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Leukemia, Myeloid, Chronic-Phase
- Neoplasm, Residual
Name | Location |
|---|---|
| OHSU Knight Cancer Institute | Portland, Oregon 97239 |
