Vaccine Therapy in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia

NCT ID: NCT00428077

Last Updated: 2011-09-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2009-04-30

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.

Conditions

Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

bcr-abl peptide vaccine

Patients will be vaccinated 15 times over 12 months with a vaccine comprised of native and synthetic break-point cluster region-Abelson murine leukemia(BCR-ABL) specific peptides and the immunologic adjuvants, Montanide ISA 51-VG.

Intervention Type: BIOLOGICAL

reverse transcriptase-polymerase chain reaction

A "baseline" reverse transcriptase-polymerase chain reaction(RT-PCR) transcript level of BCR-ABL will be determined after enrollment on study. This baseline will be used to measure response to the vaccine. Patients will have 3 quantitative RT-PCR tests for BCR-ABL transcript levels performed on their peripheral blood in the first month after enrolling on study. Peripheral blood samples will be drawn at approximately 1-month prior (about day -30), 2 weeks prior (about day -14), and the day of the first vaccination (day 0). Samples will be analyzed at a central lab and the three values will be averaged to determine a "baseline" circulating transcript level. During this one-month period, a peripheral blood sample will be analyzed to determine whether patients have a B3A2 or B2A2 junction.

Intervention Type: GENETIC

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Deininger, MD, PhD

Role: STUDY_CHAIR

OHSU Knight Cancer Institute

Locations

OHSU Knight Cancer Institute

Portland, Oregon, United States

Countries

United States

Other Identifiers

OHSU-HEM-05053-L

Identifier Type: -

Identifier Source: secondary_id

OHSU-1358

Identifier Type: -

Identifier Source: secondary_id

CDR0000526322

Identifier Type: -

Identifier Source: org_study_id