Vaccine Therapy in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia

OHSU Knight Cancer Institute

Status and phase: Terminated; Phase 2

Conditions: Leukemia

Treatments: Genetic: reverse transcriptase-polymerase chain reaction; Biological: bcr-abl peptide vaccine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00428077

CDR0000526322

OHSU-1358

OHSU-HEM-05053-L

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)