Safety and Efficacy of Combination Listeria/GVAX Immunotherapy in Pancreatic Cancer

Exclusion Criteria

• •Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions
• •Known history or evidence of brain metastases
• •Have any evidence of hepatic cirrhosis or clinical or radiographic ascites
• •Have clinically significant and/or malignant pleural effusion
• •Known or suspected hypersensitivity to any component of GVAX Pancreas vaccine or CRS-207, or known allergy to both penicillin and sulfa
• •Received an investigational product within 28 days of study treatment or planned to receive within 28 days after vaccine administration
• •Used any systemic steroids within 28 days of study treatment
• •Use more than 3 g/d of acetaminophen
• •Prosthetic joint or other artificial implant or device that cannot be easily removed (there are some exceptions)
• •Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug, or planned surgery requiring general anesthesia
• •Infection with HIV or hepatitis B or C at screening
• •Any immunodeficiency disease or immunocompromised state or active autoimmune disease or history of autoimmune disease requiring systemic steroids or other immunosuppressive treatment
• •Be pregnant or breastfeeding
• •Unable to avoid close contact with another individual known to be at high risk of listeriosis (e.g., newborn infant, pregnant woman, HIV-positive individual) during the course of CRS-207 treatment until completion of antibiotic regimen
• •Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures