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).

• Colorectal adenoma(s) ≥ 1 cm in maximal diameter
• Colorectal adenoma(s) with villous or tubulovillous histology
• 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.