| Exclusion Criteria: | 1) Subjects with gross residual disease after surgery as determined by their surgeon.
2) Subjects with concurrent chemotherapy, radiation therapy, or other immunotherapy.
3) Subjects with a history of autoimmune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis.
4) Subjects with any documented inflammatory bowel condition (such as, but not limited to, active infectious enteritis, inflammatory bowel disease, or eosinophilic enteritis).
5) Subjects with serious intercurrent chronic or acute illness such as pulmonary (asthma or COPD) or cardiac (NYHA class III or IV) or hepatic disease or other illness considered by the P.I. to constitute an unwarranted high risk for investigational drug treatment.
6) Subject with medical or psychological impediment to probable compliance with the protocol.
7) Second malignancy in the prior 5 years other than non-melanoma skin cancer, or controlled superficial bladder cancer or treated cervical carcinoma in situ.
8) Presence of an active acute or chronic infection, including urinary tract infection, HIV or viral hepatitis (as determined by HBsAg and Hepatitis C serology).
9) Subjects on steroid therapy (or other immunosuppressives such as azathioprine or cyclosporine A) are excluded on the basis of potential immune suppression. Subjects must have had 6 weeks of discontinuation of any steroid therapy prior to enrollment.
10) Subjects with egg allergies or allergies to any component of the vaccine should be excluded from the protocol.
11) 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 subject is sexually active, the subject must agree to use a medically acceptable form of birth control in order to be in this study and continue birth control for one month after the last vaccination. 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.
12) Subjects with prior or concurrent extensive eczema or acute, chronic, or exfoliative skin disorders (e.g., extensive psoriasis, burns, impetigo, or disseminated zoster, varicella zoster, severe acne, or other open rashes or wounds)
13) Subjects must be able to avoid household contact with: persons with active, or a history of, eczema or other acute or chronic skin conditions, pregnant or nursing women, children under age 5, or immunosuppressed or immunodeficient persons. Unable to avoid close contact or household contact with the following high-risk individuals for 3 weeks after the DAY 0 vaccination: Children under the age of 5; Pregnant or nursing women; Individuals with prior or concurrent extensive eczema or other eczematoid skin disorders; Immunocompromised individuals (by disease or therapy) such as those with AIDS;
14) Subjects with a history of allergy or untoward reaction to prior vaccinia (smallpox) vaccination.
15) Allergy or untoward reaction to prior GM-CSF administration.
16) Active infection within 72 hours of vaccination.
17) Subjects with a history of myocardial infarction or cerebrovascular accident within one year of registration to the study, and/or unstable or uncontrolled angina. |