Trial record 1 of 1 for:    NCT00773097
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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:
Information provided by (Responsible Party):
Robert Schoen, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00773097
First received: October 15, 2008
Last updated: February 12, 2014
Last verified: February 2014

October 15, 2008
February 12, 2014
October 2008
October 2011   (final data collection date for primary outcome measure)
Number of Participants With Anti Muc-1 Antibody [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
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.
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 ]
Complete list of historical versions of study NCT00773097 on ClinicalTrials.gov Archive Site
  • Number of Participants With Autoimmune Response to Muc-1 Vaccine [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Laboratory monitoring including Toxicity laboratory test or monitored through out the study up to week 54.
  • 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 ]
Not Provided
Not Provided
 
Study of the MUC1 Peptide-Poly-ICLC Adjuvant Vaccine in Individuals With Advanced Colorectal Adenoma
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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Risk for Colorectal Cancer
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.
Experimental: MUC1 Poly-ICLC
Intervention: Biological: MUC1 - Poly ICLC
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.
 
Completed
46
October 2012
October 2011   (final data collection date for primary outcome measure)

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.
Both
40 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00773097
PRO07030214
Yes
Robert Schoen, University of Pittsburgh
University of Pittsburgh
National Cancer Institute (NCI)
Principal Investigator: Robert E Schoen University of Pittsburgh
University of Pittsburgh
February 2014

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