Clinical Trial: Study of the MUC1 Peptide-Poly-ICLC Adjuvant Vaccine in Individuals With Advanced Colorectal Adenoma

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

Official Title: Study of the MUC1 Peptide - Poly-ICLC Adjuvant Vaccine in Individuals With Advanced Colorectal Adenoma

Brief Summary:

The purpose of this study is to evaluate the immune response to MUC1 - poly-ICLC vaccine, an investigational or study vaccine. The MUC1 - poly-ICLC vaccine is being tested in persons with a history of advanced adenomatous polyps, the precursor to colorectal cancer. The MUC1 - poly-ICLC vaccine is being developed to prevent polyps from advancing into colon cancer and to prevent polyps from recurring.

MUC1 is mucus that is normally present on the lining of the human colon. However, MUC1 is expressed in a larger amount and in a modified form on adenomatous polyps and colorectal cancer. These changes in MUC1 are thought to be part of the process of progression from adenomas toward cancer. The goal of a vaccine is to help the immune system in the body identify the changes in MUC1 that accompany the progression to cancer and eliminate the abnormal cells that make abnormal MUC1.


Detailed Summary: This is a phase II trial designed to assess antibody and T cell responses to MUC1 vaccine among subjects at increased risk for colorectal cancer by virtue of a history of advanced adenoma. The primary objective is to evaluate the immunogenicity of a combination of the 100mer MUC1 peptide and adjuvant Poly-ICLC in boosting the immune response to MUC1. Among the secondary objectives is to determine if anti-MUC1 immunity, preexisting or vaccine induced, has an effect on the recurrence of polyps. Subjects with a history of advanced adenoma will be recruited for MUC1 vaccination. Vaccine will be administered at weeks 0, 2, and 10. Some subjects may have pre-existing immunity to MUC1, and this will be accounted for in the analytic phase. However, all subjects will be administered the vaccine, regardless of baseline antibody status. To insure accurate standardization in measurement and assessment of antibody levels, assays for baseline antibody status will be done at the same time as those for response to vaccine.
Sponsor: University of Pittsburgh

Current Primary Outcome: Number of Participants With Anti Muc-1 Antibody [ Time Frame: 52 weeks ]

Evaluation of the immune response to MUC1 peptide vaccine administered with Poly-ICLC, measured by Anti MUC1 antibody, in patients with a history of advanced colorectal adenoma.


Original Primary Outcome: Evaluate the immune response to MUC1 peptide vaccine administered with Poly-ICLC, measured by Anti MUC1 antibody, in patients with a history of advanced colorectal adenoma. [ Time Frame: 52 weeks ]

Current Secondary Outcome:

  • Number of Participants With Autoimmune Response to Muc-1 Vaccine [ Time Frame: 52 weeks ]
    Evaluate for autoimmune response by measuring the Anti-muc-1 IgG antibodies to the muc-1 vaccine.
  • Number of Participants With Adverse Events Associated With the Study Agent [ Time Frame: 54 weeks ]
    Laboratory monitoring including Toxicity laboratory test or monitored through out the study up to week 54.


Original Secondary Outcome:

  • To monitor specific anti MUC1 isotypes such as anti-MUC1 IgM and IgG antibodies [ Time Frame: 52 weeks ]
  • To monitor adverse events associated with the study agent [ Time Frame: 52 weeks ]
  • To evaluate the correlation between the anti-MUC1 response (preexistent and/or induced by the vaccine) and polyp recurrence rate in patients with advanced adenoma [ Time Frame: 52 weeks ]


Information By: University of Pittsburgh

Dates:
Date Received: October 15, 2008
Date Started: October 2008
Date Completion:
Last Updated: February 12, 2014
Last Verified: February 2014