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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Robert Schoen, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00773097
First received: October 15, 2008
Last updated: January 16, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Risk for Colorectal Cancer
 Biological: MUC1 - Poly ICLC
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Study of the MUC1 Peptide - Poly-ICLC Adjuvant Vaccine in Individuals With Advanced Colorectal Adenoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To monitor specific anti MUC1 isotypes such as anti-MUC1 IgM and IgG antibodies [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • To monitor adverse events associated with the study agent [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: October 2008
Study Completion Date: October 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MUC1 Poly-ICLC 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.

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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00773097

Locations
United States, Pennsylvania
Digestive Disorders Clinic
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Cancer Institute (NCI)
Investigators
Principal Investigator: Robert E Schoen University of Pittsburgh
  More Information

Publications:

Responsible Party: Robert Schoen, Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00773097     History of Changes
Other Study ID Numbers: PRO07030214, NIH grant 5P01 CA73743-08
Study First Received: October 15, 2008
Last Updated: January 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
Prevention
Colorectal Cancer

Additional relevant MeSH terms:
Adenoma
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
 Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Poly ICLC
Interferon Inducers
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 13, 2013