Vaccine Therapy in Treating Patients With Stage III Colon or Rectal Cancer

Inclusion Criteria

• Histologically confirmed stage III colorectal cancer as determined by American Joint Committee on Cancer (AJCC) 7th edition
• Subjects must have received adjuvant post-operative chemotherapy meeting the following requirements: * Completed chemotherapy as per the discretion of their physician * Chemotherapy must have been completed within 1-6 months of starting study treatment
• Subjects with rectal cancer must have received chemotherapy meeting the following requirements: * Completed chemotherapy as per the discretion of their physician * Chemotherapy must have been completed within 1-6 months of starting study treatment
• Karnofsky performance status greater than or equal to 70%
• Estimated life expectancy > 6 months and not expected to require further systemic chemotherapy for at least 3 months
• Serum creatinine =< 1.5 x upper limit of normal OR creatinine clearance on a 24-h urine collection of >= 60 mL/min
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x the upper limits of normal
• Total bilirubin =< 1.5 x upper limit of normal OR in patients with Gilbert’s syndrome, a total bilirubin =< 3.0
• Granulocyte count >= 1,500/mm3
• Platelet count >= 100,000/
• Ability to understand and provide signed informed consent that fulfills Institutional Review Board’s guidelines

Exclusion Criteria

• Patients with active cytotoxic chemotherapy or radiation therapy are excluded
• Evidence of metastatic disease on imaging studies performed at the discretion of their physician
• Patients with a history of autoimmune disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis
• Patients with serious intercurrent chronic or acute illness, such as cardiac disease (New York Heart Association [NYHA] class III or IV), hepatic disease, or other illness considered by the principal investigator as unwarranted high risk for investigational drug treatment
• Patients with a medical or psychological impediment to probable compliance with the protocol should be excluded
• Concurrent (or within the last 5 years) second malignancy other than non-melanoma skin cancer, cervical carcinoma in situ, or controlled superficial bladder cancer
• Evidence of immune dysfunction as listed below: * Human immunodeficiency virus (HIV) positivity * Active autoimmune diseases requiring treatment or a history of autoimmune disease that might be stimulated by vaccine treatment; however, patients with vitiligo may be enrolled * Concurrent use of systemic steroids, except for physiologic doses of systemic steroid replacement or local (topical, nasal, or inhaled) steroid use; limited doses of systemic steroids (e.g., in patients with exacerbations of reactive airway disease or to prevent intravenous [IV] contrast allergic reaction or anaphylaxis in patients who have known contrast allergies) are allowed
• Presence of an active acute or chronic infection including: a urinary tract infection as determined by their physician, HIV (as determined by enzyme-linked immunosorbent assay [ELISA] and confirmed by Western blot) or viral hepatitis (as determined by hepatitis B surface antigen [HBsAg] and hepatitis C serology)
• Patients with allergies to any component of the vaccine will be excluded from the protocol
• Pregnant and nursing women should be excluded from the protocol; if the patient is sexually active, the patient must agree to use a medically acceptable form of birth control while receiving treatment and for a period of 4 months following the last vaccination therapy; it is not known whether the treatment used in this study could affect the sperm and could potentially harm a child that may be fathered while on this study
• Patients with acute or chronic skin disorders that will interfere with injection into the skin of the extremities or subsequent assessment of potential skin reactions will be excluded