IL-2 Expressing, Attenuated Salmonella Typhimurium in Unresectable Hepatic Spread

Exclusion Criteria

• •Unable to take oral drugs or clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to: malabsorption syndrome, major resection of stomach or small bowel
• •Receiving any other investigational agents
• •Known central nervous system metastases
• •Residing in a household or having close contact with pregnant women, young children (under the age of 1 year) or immune compromised persons
• •Engaged in activities that might pose a risk for widespread dissemination of this organism, including, but not limited to; health care, child care, or food service.
• •Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations.
• •Pregnant or breastfeeding. Women of child bearing potential must have a negative serum or urine pregnancy test within 7 days of prior to the start of treatment. Pregnancy testing is not required for post-menopausal or surgically sterilized women. Breast-feeding mothers will be asked to discontinue feeding infants prior to enrolling in the study.
• •Known HIV infection, need for chronic steroids or other immunosuppressant drugs, or other medical conditions that in the investigator's opinion result in a significant degree of immunosuppression. Patients without identified HIV risk factors are not required to have HIV testing to be eligible.
• •Known active hepatitis B or C infection
• •Known HLA B27
• •Have permanent artificial implants (such as, but not limited to prosthetic valves and joints.)
• •Any other condition which in the investigator's opinion renders the patient at high risk for overwhelming infection