Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia

Thank you

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 InstitutePortland, Oregon  97239