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

Phase 2
40 Years
70 Years
Not Enrolling
Risk for Colorectal Cancer

Thank you

Trial Information

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

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.

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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

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.

Outcome Time Frame:

52 weeks

Safety Issue:


Principal Investigator

Robert E Schoen

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh


United States: Food and Drug Administration

Study ID:




Start Date:

October 2008

Completion Date:

October 2012

Related Keywords:

  • Risk for Colorectal Cancer
  • Prevention
  • Colorectal Cancer
  • Adenoma
  • Colorectal Neoplasms



Digestive Disorders ClinicPittsburgh, Pennsylvania  15213