Immunotherapy With CEA(6D) VRP Vaccine (AVX701) in Patients With Stage III Colorectal Cancer

Inclusion Criteria:

- Histologically confirmed stage III colorectal cancer as determined by AJCC 7th
edition.

- Subjects must have received adjuvant post-operative chemotherapy meeting the following
requirements:

1. Chemotherapy must have consisted of a 5-fluorouracil-based regimen with or
without oxaliplatin for at least 6 cycles or capecitabine with or without
oxaliplatin for 4 cycles.

2. 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:

1. Neoadjuvant chemotherapy, if utilized, must have consisted of a
5-fluorouracil-based regimen (or capecitabine) with radiation

2. Adjuvant chemotherapy must have consisted of a 5-fluorouracil-based regimen with
or without oxaliplatin for at least 6 cycles or capecitabine with or without
oxaliplatin for 4 cycles

3. 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.

- Age ≥ 18 years

- Adequate hematologic function: WBC ≥ 3000/microliter, Hgb ≥ 9 g/dL (may transfuse or
use erythropoietin to achieve this level), platelets ≥ 100,000/microliter

- Adequate renal and hepatic function, with serum creatinine < 1.5 mg/dL, bilirubin <
1.5 mg/dL (except for Gilbert's syndrome which will allow bilirubin ≤ 2.0 mg/dL), ALT
and AST ≤ 2.5 x upper limit of normal.

- Ability to understand and provide signed informed consent that fulfills Institutional
Review Board's guidelines.

- Ability to return to Duke University Medical Center for adequate follow-up, as
required by this protocol

Exclusion Criteria:

- Patients with active cytotoxic chemotherapy or radiation therapy should be excluded.
There are no exclusions based on the number of prior chemotherapy, biologic, hormonal,
or experimental regimens. There 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.

- Evidence of metastatic disease.

- 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
(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.

- Presence of an active acute or chronic infection including: a urinary tract infection
, HIV (as determined by ELISA and confirmed by Western Blot) or viral hepatitis (as
determined by HBsAg and Hepatitis C serology). Patients with HIV are excluded based on
immuno-suppression, which may render them unable to respond to the vaccine; patients
with chronic hepatitis are excluded because of concern that hepatitis could be
exacerbated by the injections.

- Patients on steroid therapy (or other immuno-suppressives, such as azathioprine or
cyclosporin A) are excluded on the basis of potential immune suppression. Patients
must have had 6 weeks of discontinuation of any steroid therapy (except that used as
pre-medication for chemotherapy or contrast-enhanced studies) prior to enrollment.

- 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 since this research
may have unknown and harmful effects on an unborn child or on young children. 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.