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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00773097
Recruitment Status : Completed
First Posted : October 16, 2008
Results First Posted : February 3, 2014
Last Update Posted : January 7, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Robert Schoen, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE October 15, 2008
First Posted Date  ICMJE October 16, 2008
Results First Submitted Date  ICMJE July 17, 2013
Results First Posted Date  ICMJE February 3, 2014
Last Update Posted Date January 7, 2019
Study Start Date  ICMJE October 2008
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2013)
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 Measures  ICMJE
 (submitted: October 15, 2008)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2014)
  • 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 Measures  ICMJE
 (submitted: October 15, 2008)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the MUC1 Peptide-Poly-ICLC Adjuvant Vaccine in Individuals With Advanced Colorectal Adenoma
Official Title  ICMJE 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 Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Risk for Colorectal Cancer
Intervention  ICMJE Biological: MUC1 - Poly ICLC
The vaccine will be administered on an outpatient basis in the Digestive Disorders Clinic. The total volume of each dose of vaccine MUC1+ POLY-ICLC will be approximately 250 microliters subcutaneously (SQ) in the upper thigh. The site of injection will remain the same thigh, to enhance the potential immune response.
Study Arms  ICMJE Experimental: MUC1 Poly-ICLC
Intervention: Biological: MUC1 - Poly ICLC
Publications * Kimura T, McKolanis JR, Dzubinski LA, Islam K, Potter DM, Salazar AM, Schoen RE, Finn OJ. MUC1 vaccine for individuals with advanced adenoma of the colon: a cancer immunoprevention feasibility study. Cancer Prev Res (Phila). 2013 Jan;6(1):18-26. doi: 10.1158/1940-6207.CAPR-12-0275. Epub 2012 Dec 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 16, 2013)
46
Original Estimated Enrollment  ICMJE
 (submitted: October 15, 2008)
65
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

-Age 40 - 70 years of age.

  • History of any of the following conditions (operative notes, endoscopy reports, and/or pathology reports must be reviewed locally to confirm that the candidate meets at least one of the following entry criteria).

    1. Colorectal adenoma(s) ≥ 1 cm in maximal diameter
    2. Colorectal adenoma(s) with villous or tubulovillous histology
    3. Colorectal adenoma(s) with high-grade dysplasia
  • Willingness to avoid pregnancy or impregnate (see below) for the period of active study (1 year).
  • ECOG performance status 0 or 1
  • Hemoglobin greater than 95% of the lower limit of institutional normal. Platelets ≥100,000/µL.
  • AST (SGOT), ALT (SGPT), alkaline phosphatase, total bilirubin, BUN, creatinine ≤ 1.5x upper limit of institutional normal.
  • ANA < 1:160

Exclusion Criteria:

  • Receiving any other investigational agents.
  • Presence of an active acute or chronic infection
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agents.
  • History of heritable cancer syndrome (FAP, HNPCC)
  • Patients with a history of auto-immune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, scleroderma, or multiple sclerosis.
  • History of malignancy < 5 years prior to the Registration/Randomization evaluation, excluding non-melanoma skin cancer.
  • Any use of oral corticosteroids ≤ 12 weeks prior to Registration/Randomization.
  • Current or planned use of immunomodulators including: Remicade, 6-MP (Mercaptopurine), Methotrexate, cyclosporine, or other immunomodulatory drugs.
  • Pregnant women, because the teratogenic or abortifacient effects of the study agents remain incompletely defined. Breastfeeding women, because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study agents.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00773097
Other Study ID Numbers  ICMJE PRO07030214
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Robert Schoen, University of Pittsburgh
Original Responsible Party Robert E. Schoen, University Pittsburgh Medical Center
Current Study Sponsor  ICMJE Robert Schoen
Original Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Robert E Schoen University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP