A Phase I/II Study With CEA(6D) VRP Vaccine in Patients With Advanced or Metastatic CEA-Expressing Malignancies

Inclusion Criteria:

Cohorts 1-4 only:

* Histologically confirmed diagnosis of metastatic malignancy due to a tumor expressing CEA.
* The tumor must express CEA as defined by immunohistochemical staining, CEA blood level, or a tumor known to be universally CEA positive.
* Must have received treatment with standard therapy having a possible overall survival benefit or refused such therapy.
* Must have received and progressed through at least one line of palliative chemotherapy for colorectal, breast, lung, or pancreatic cancer. For other malignancies, if a first line therapy with survival or palliative benefit exists, it should have been administered and there should have been progressive disease.

Cohort 5 Only:

* Histologically confirmed colon cancer (rectal cancer excluded). Since colon cancer is nearly universally CEA positive, CEA staining is not required.
* Documented stage III colon cancer with no evidence of disease.
* One to six months following standard post-operative adjuvant treatment, which should have consisted of 5-fluorouracil and folinic acid or capecitabine with or without oxaliplatin for 4-6 months)

All Cohorts:

* Karnofsky performance status ≥ 70%.
* Estimated life expectancy \> 6 months and not expected to require further systemic chemotherapy for at least 3 months.
* Age ≥ 18 years.
* Adequate hematologic function (WBC ≥ 3000/microliter, hemoglobin ≥ 9 g/dL, and platelets ≥ 100,000/microliter).
* Adequate renal and hepatic function, (serum creatinine \< 1.5 mg/dL, bilirubin ≤ 1.5 mg/dL, and ALT and AST ≤ 2.5 x upper limit of normal).
* Patients who have received CEA-targeted immunotherapy, if treatment was discontinued at least 3 months before enrollment.
* Patients who are taking medications that do not have a known history of immunosuppression are eligible for this trial.
* Ability to understand and provide signed informed consent.
* Ability to return to Duke University Medical Center for adequate follow-up, as required by protocol.

Exclusion Criteria:

* Concurrent cytotoxic chemotherapy or radiation therapy (must be at least 3 months between any prior CEA-targeted immunotherapy and study treatment and at least 4 weeks between any other prior therapy and study treatment).
* Patients with previously resected brain metastases will be permitted if a CT or MRI scan shows no metastasis within 1 month before enrollment.
* History of autoimmune disease.