Study of the MUC1 Peptide-Poly-ICLC Adjuvant Vaccine in Individuals With Advanced Colorectal Adenoma
Condition: Risk for Colorectal Cancer
MeSH terms: Colorectal Neoplasms; Adenoma
Intervention: MUC1 - Poly ICLC
Intervention description: 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.
Intervention MeSH terms: Poly ICLC
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 40 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Prevention; Colorectal Cancer

Summary:

      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.
    

Eligibility criteria:

        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.