Clinical Trial: Synthetic Vaccine in Patients With Chronic Myeloid Leukemia and Minimal Residual Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Pilot Phase II Trial of a Synthetic Tumor-Specific Breakpoint Peptide Vaccine in Patients With Chronic Myeloid Leukemia (CML) and Minimal Residual Disease

Brief Summary: The goal of this clinical research study is to learn if giving 1 of 2 CML (Chronic Myeloid Leukemia) vaccines (CML-VAX B2 or CML-VAX B3) together with imatinib mesylate can decrease or eliminate all evidence of disease in patients who have CML that is in remission after treatment with imatinib mesylate, but who still have small amounts of detectable disease.

Detailed Summary:

Patients who are eligible to take part in this study have already responded well to treatment with imatinib mesylate. Your disease is in what is called a complete cytogenetic remission (i.e., The Philadelphia chromosome is no longer detectable.). However, there is still a small amount of disease that can be detected using the most sensitive techniques available. CML-VAX B2 and CML-VAX B3 are experimental vaccines made from the proteins that cause leukemia cells in CML to behave abnormally. Imatinib mesylate is the standard therapy for CML and blocks the function of this protein.

Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have a complete physical exam and medical history. Blood (about 2 tablespoons) will be collected for routine tests. You will also have a bone marrow aspiration and a chromosome analysis of the number of chromosomes in the bone marrow. To collect a bone marrow aspiration, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle. Women who are able to have children must have a negative blood or urine pregnancy test.

You will also have some additional blood work (about 1 tablespoon) to test the levels of leukemia in your blood. If you agree to participate in this study, this test will be repeated 2 more times, about 2 weeks apart, before you can start vaccination. This is done to get a good measure of the amount of disease you may have.

There are 2 different vaccines that can be used in this study, CML-VAX B2 and CML-VAX B3. If you are found to be eligible to take part in this study, you will only receive one of them. Which
Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: Response: One Log Decrease in BCR-ABL [ Time Frame: 12 months ]

Molecular response defined as reduction by one log of the circulating peripheral blood for reverse transcription polymerase chain reaction (RT-PCR) transcripts of BCR-ABL (tumor-specific oncogenic fusion protein) after two consecutive measurements. RT-PCR performed at 3 month intervals. Response categorized as either 'No Decrease' or 'Decrease' if one log reduction in BCR-ABL detected.


Original Primary Outcome: To evaluate the anti-leukemic effects of vaccination with CML breakpoint peptides as measured by a one-log decrease in circulating BCR-ABL transcripts using reverse transcription polymerase chain reaction (RT-PCR).

Current Secondary Outcome:

Original Secondary Outcome:

  • 1. To evaluate the percentage of patients who become RT-PCR negative for BCR-ABL transcripts during the study period.
  • 2. To determine whether responses in patients with B3A2 versus B2A2 junctions, immunized with junction-specific peptide vaccines, differ.
  • 3. To evaluate the immunologic responses to a vaccine containing native and synthetic CML peptides over 1 year.
  • 4. To determine whether responses to peptide vaccine correlate with immunologic responses.


Information By: M.D. Anderson Cancer Center

Dates:
Date Received: December 19, 2005
Date Started: December 2005
Date Completion:
Last Updated: August 1, 2012
Last Verified: August 2012