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

January 3, 2019 updated by: Robert Schoen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

46

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
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Digestive Disorders Clinic

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

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
52 weeks
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.
54 weeks

Collaborators and Investigators

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

Sponsor

Robert Schoen

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Robert E Schoen, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2008

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

October 15, 2008

First Submitted That Met QC Criteria

October 15, 2008

First Posted (Estimate)

October 16, 2008

Study Record Updates

Last Update Posted (Actual)

January 7, 2019

Last Update Submitted That Met QC Criteria

January 3, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO07030214

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Risk for Colorectal Cancer

Clinical Trials on MUC1 - Poly ICLC

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe