Vaccine Therapy in Treating Patients With Newly Diagnosed Advanced Colon Polyps
Condition: Colorectal Adenoma; Colorectal Adenoma With Severe Dysplasia; Colorectal Tubulovillous Adenoma
MeSH terms: Adenoma
Intervention: Laboratory Biomarker Analysis; MUC1 Peptide-Poly-ICLC Vaccine; Quality-of-Life Assessment; Saline
Intervention description: Correlative studies; Given SC; Ancillary studies; Given SC
Intervention MeSH terms: Poly ICLC
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 110.0
Sex: All
Minimum age: 40 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This randomized phase II clinical trial studies how well MUC1 peptide-poly-ICLC adjuvant
      vaccine works in treating patients with newly diagnosed advanced colon polyps (adenomatous
      polyps). Adenomatous polyps are growths in the colon that may develop into colorectal cancer
      over time. Vaccines made from peptides may help the body build an effective immune response
      to kill polyp cells. MUC1 peptide-poly-ICLC adjuvant vaccine may also prevent the recurrence
      of adenomatous polyps and may prevent the development of colorectal cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of at least one of the following conditions in the previous 12 months:

               -  Colorectal adenoma(s) >= 1 cm in maximal diameter

               -  Colorectal adenoma(s) with villous or tubulovillous histology

               -  Colorectal adenoma(s) with high grade (severe) dysplasia

          -  Presumptive evidence that all adenomatous lesions, including qualifying advanced
             adenoma, have been completely removed

          -  Ability to understand and the willingness to sign a written informed consent document

          -  Willingness to undergo screening tests and procedures

          -  Willingness to provide blood samples for toxicity monitoring and research purposes

          -  Not pregnant or nursing; note: a negative (serum or urine) pregnancy test must be
             documented =< 7 days prior to registration/randomization for women of childbearing
             potential

          -  Willingness to employ adequate contraception through week 53 of the study; note: women
             of childbearing potential and men must agree to use adequate contraception (hormonal,
             barrier method of birth control, abstinence) prior to study entry and for the period
             of active vaccination (through week 53); should a woman become pregnant or suspect she
             is pregnant while participating in this study, she should inform her physician
             immediately

          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)

          -  Hemoglobin greater than 90% of the lower limit of institutional normal

          -  Platelets >= 100 B/L (10^9/L)

          -  White blood cell (WBC) > 2.5 B/L (10^9/L)

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]),
             alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 x
             institutional upper limit of normal

          -  Alkaline phosphatase =< 1.5 x institutional upper limit of normal

          -  Total bilirubin =< 1.5 x institutional upper limit of normal

          -  Blood urea nitrogen (BUN) =< 1.5 x institutional upper limit of normal

          -  Creatinine =< 1.5 x institutional upper limit of normal

          -  Antinuclear antibody (ANA) test result excludes overt autoimmune disease; note: test
             result may be reported in any of the following formats: =< 1:160, negative, or < 1.0

        Exclusion Criteria:

          -  History of any colorectal cancer

          -  History of other malignancy =< 5 years prior to the registration/randomization
             evaluation, with the exception of basal cell or squamous cell skin cancer

          -  Presence of an active acute or chronic infection or uncontrolled illness including,
             but not limited to unstable congestive heart failure, unstable angina pectoris,
             cardiac arrhythmia, or psychiatric illness/social situations that would limit
             compliance with study requirements

          -  Acquired immunosuppressive diseases such as active human immunodeficiency virus (HIV)
             infection or congenital diseases of immunity

          -  History of heritable cancer syndrome (familial adenomatous polyposis [FAP], hereditary
             nonpolyposis colorectal cancer [HNPCC])

          -  History of auto-immune disease such as, but not restricted to, inflammatory bowel
             disease, systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis,
             scleroderma, multiple sclerosis, Hashimoto's thyroiditis, or Grave's disease

          -  Current or planned use of immunomodulators including: infliximab, 6-MP
             (mercaptopurine), methotrexate, cyclosporine, or other immunomodulatory drugs

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to the study agent

          -  Pregnant women

          -  Breastfeeding women

          -  Diagnosis of nonalcoholic steatohepatitis (NASH) and a NAFLD (nonalcoholic fatty liver
             disease) activity score (NAS) >= 5; NOTES and EXCEPTIONS: NAS is based on findings
             from a liver biopsy; participants with NAS of =< 2 are eligible for enrollment;
             participants with NAS of 3-4 must be discussed with the principal investigator and
             Division of Cancer Prevention (DCP) before enrollment to consider other risk factors
             (i.e., obesity, alcohol intake); participants with a prior diagnosis of NASH and no
             available NAS must be discussed with the principal investigator and DCP before
             enrollment to considered risk factors (i.e., obesity, alcohol intake)

          -  Receiving any other investigational agent =< 3 months prior to
             registration/randomization, except innocuous agents with no known interaction with the
             study agent (e.g., standard dose multivitamins or topical agents for limited skin
             conditions)

          -  Any use of oral corticosteroids =< 12 weeks prior to registration/randomization