Vaccine Therapy in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia - Full Text View

Sponsors and Collaborators:	Oregon Health and Science University Cancer Institute National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00428077

Purpose

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	Intervention	Phase
Leukemia	Drug: bcr-abl peptide vaccine Procedure: reverse transcriptase-polymerase chain reaction	Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

U.S. FDA Resources

Study Type:	Interventional
Study Design:	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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Antileukemic effects of vaccine, as measured by a decrease in circulating BCR-ABL transcripts by reverse-transcriptase polymerase chain reaction (RT-PCR) [ Designated as safety issue: No ]
Percentage of patients who become RT-PCR-negative for BCR-ABL transcripts [ Designated as safety issue: No ]
Comparison of response in patients with B3A2 junctions vs B2A2 junctions [ Designated as safety issue: No ]
Immunologic response over 1 year [ Designated as safety issue: No ]
Correlation of response with specific HLA types [ Designated as safety issue: No ]
Safety of vaccine [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	October 2005
Estimated Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the antileukemic effects of tumor-specific 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428077

Locations

United States, Oregon
Oregon Health and Science University Cancer Institute
Portland, Oregon, United States, 97239-3098

Sponsors and Collaborators

Oregon Health and Science University Cancer Institute

National Cancer Institute (NCI)

Investigators

Study Chair:

Michael Deininger, MD, PhD

Oregon Health and Science University Cancer Institute

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Responsible Party:	Oregon Health and Science University Cancer Institute ( Michael Deininger )
Study ID Numbers:	CDR0000526322, OHSU-HEM-05053-L, OHSU-1358
Study First Received:	January 25, 2007
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00428077
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

Philadelphia chromosome positive chronic myelogenous leukemia
chronic phase chronic myelogenous leukemia

Study placed in the following topic categories:

Philadelphia Chromosome
Neoplasm, Residual
Leukemia
Chronic myelogenous leukemia
Hematologic Diseases

Myeloproliferative Disorders
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Leukemia, Myeloid
Bone Marrow Diseases

Additional relevant MeSH terms:

Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009