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

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.