Vaccine Therapy in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia

August 31, 2011 updated by: OHSU Knight Cancer Institute

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

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.

Study Overview

Status

Terminated

Conditions

Leukemia

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Oregon
  - Portland, Oregon, United States, 97239-3098
    - OHSU Knight Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. .	One-log decrease in circulating BCR-ABL transcripts (RT-PCR) that persists for at least three months during the 1-year treatment period.	Every 3 months for the duration of the 1-year treatment period. .
Percentage of Patients Who Become RT-PCR-negative for BCR-ABL Transcripts Time Frame: 12-24 Months		12-24 Months
Comparison of Response in Patients With B3A2 Junctions vs B2A2 Junctions Time Frame: 12-24 Months		12-24 Months
Immunologic Response Over 1 Year Time Frame: 12 months		12 months
Correlation of Response With Specific HLA Types Time Frame: 12-24 Months		12-24 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	Weeks 2, 4, 6, 9, and monthly thereafter up to 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OHSU Knight Cancer Institute

Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair: Michael Deininger, MD, PhD, OHSU Knight Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

January 25, 2007

First Submitted That Met QC Criteria