Vaccine Therapy in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia

This study has been 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(Withdrawn because there were no dramatic changes in the main endpoint, as well as low enrollment numbers.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.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00428077
First received: January 25, 2007
Last updated: August 31, 2011
Last verified: August 2011
  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
Biological: bcr-abl peptide vaccine
Genetic: reverse transcriptase-polymerase chain reaction
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: 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

Resource links provided by NLM:


Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:
  • 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. . ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Comparison of Response in Patients With B3A2 Junctions vs B2A2 Junctions [ Time Frame: 12-24 Months ] [ Designated as safety issue: No ]
  • Immunologic Response Over 1 Year [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Correlation of Response With Specific HLA Types [ Time Frame: 12-24 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Enrollment: 4
Study Start Date: October 2005
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: 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.
    Genetic: 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.
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Oregon
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239-3098
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
Study Chair: Michael Deininger, MD, PhD OHSU Knight Cancer Institute
  More Information

No publications provided

Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00428077     History of Changes
Other Study ID Numbers: CDR0000526322, OHSU-HEM-05053-L, OHSU-1358
Study First Received: January 25, 2007
Results First Received: May 26, 2011
Last Updated: August 31, 2011
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by OHSU Knight Cancer Institute:
Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia
chronic phase chronic myelogenous leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Neoplasm, Residual
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on August 20, 2014