Phase I Study of Ad5-hGCC (Human Guanylyl Cyclase C)-PADRE in Stage I/II Colon Cancer

Inclusion Criteria: * Male and Female African American or Caucasian subjects older than 18 years of age. Race will be defined by the subject. * Stage I or stage II (pN0) colon cancer within 3 years of surgery * Competent immune system, defined by the ability to make a delayed type hypersensitivity (DTH) reaction to at least one of the following: candida, mumps, tetanus or trichophyton * Adequate renal, liver, and bone marrow functions: Serum creatinine ≤ 2.0 mg/dl, Hemoglobin ≥ 10.0 g/dl WBC (white blood cells) ≥ 3,000 /mm3, platelet count ≥ 100,000/mm3, total bilirubin ≤2.0 mg/ml, and albumin ≥ 3.0 g/dl * Lymph node specimens available for quantification of occult metastases * Minimum of 2 months and maximum of 36 months since surgery * No clinical or laboratory evidence of local or systemic recurrence at entry to the study * Expected survival of at least 6 months * Karnofsky performance status ≥ 80 (ECOG 0 or 1) * Willingness and ability to understand and give informed consent and follow the procedures described in the protocol Exclusion Criteria: * Failure to meet any of the inclusion criteria above * Rectal cancer * Prior chemotherapy/radiotherapy/immunotherapy/experimental medications for colon cancer * Prior splenectomy * Concurrent use of systemic steroids or immunosuppressive drugs (Note: topical or inhaled aerosol steroid therapies are not contraindicated for participation in the study) * HIV-positive by ELISA, confirmed by Western blot * Active autoimmune disea…