Vaccine Therapy and Radiation to Liver Metastasis in Patients With CEA-Positive Solid Tumors

Exclusion Criteria

• •Patients should have no evidence of being immunocompromised as listed below.
• •Human immunodeficiency virus positivity due to the potential for decreased tolerance and may be at risk for severe side effects
• •Autoimmune diseases such as, Addison's disease, Hashimoto's thyroiditis, or systemic lupus erythematous, Sjogren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome active Grave's disease. Altered immune function in prospective participants will be assessed through a thorough history and physical examination. Any clinical suspicion of autoimmune dysfunction will be worked up before enrollment on to the study. This requirement is due to the potential risks of exacerbating autoimmunity
• •Hepatitis B or C positivity
• •Prior radiation to greater than 50% of all nodal groups
• •Prior whole liver radiation
• •Concurrent use of systemic steroids, except for physiologic doses for systemic steroid replacement or local (topical, nasal, or inhaled) steroid use. Steroid eye drops are contraindicated for at least 2 weeks prior vaccinia vaccination and at least 4 weeks post vaccinia vaccination.
• •Prior splenectomy
• •History of allergy or untoward reaction to prior vaccination with vaccinia virus or to any component of the vaccinia vaccine regimen.
• •Pregnant or breast-feeding women.
• •Recombinant vaccinia vaccination should not be administered if any of the following apply to either recipients, or for at least three weeks after vaccination (i.e., until the scab has separated from the skin and the underlying skin has healed), their close household contacts (close household contacts are those who share housing or have close physical contact): persons with active or a history of eczema or other eczematoid skin disorders; those with other acute, chronic or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds) until condition resolves; pregnant or nursing women; children 5 years of age and under; and immunodeficient or immunosuppressed persons (by disease or therapy), including HIV infection.
• •Serious intercurrent medical illness which would interfere with the ability of the patient to carry out the treatment program, including, but not limited to, inflammatory bowel disease, Crohn's disease, ulcerative colitis, or active diverticulitis.
• •Known brain metastasis, history of seizures, encephalitis, or multiple sclerosis.
• •Concurrent chemotherapy.
• •Serious hypersensitivity reaction to egg products.
• •Clinically significant cardiomyopathy requiring treatment.
• •Chronic liver disease including end stage cirrhosis, or chronic active hepatitis as indicated by surface antigen or core antibody.