Safety and Immunogenicity of Recombinant DNA and Adenovirus Expressing L523S Protein in Early Stage Non-Small Cell Lung Cancer

Exclusion Criteria

• •Received pre- or post-operative radiotherapy
• •Received prior biologic, immunologic, or gene therapy for cancer
• •Received an investigational drug (new chemical entity) within three months of study entry
• •Received antibiotics within 2 weeks of Day 0 visit
• •Received systemic or inhaled corticosteroids or immunosuppressive therapy within 4 weeks of Day 0 visit (Use of topical corticosteroids and/or eye drops containing glucocorticosteroids is acceptable)
• •History of active autoimmune diseases such as, but not limited to, systemic lupus erythematosis, sarcoidosis, rheumatoid arthritis, glomerulonephritis, vasculitis, or inflammatory bowel disease
• •History of bleeding in stools and/or diarrhea within 4 weeks of Day 0 visit
• •History of anaphylaxis or severe allergic reaction to vaccines or unknown allergens
• •Received any commercial vaccine within 2 weeks of Day 0 visit
• •Received a major organ allograft
• •Current or previous diagnosis of paraneoplastic syndrome
• •Evidence of a clinically significant active pulmonary infection, emphysema, FeV1 less than or equal to 50% predicted, DLCO less than or equal to 50% predicted, pulse oximetry less than or equal to 92% at the time of study entry
• •Known to be HIV positive
• •Results of virology screening indicate positive serology for HCV (hepatitis C virus) and/or HBsAG (hepatitis B surface antigen). Positive serology for HBV antibodies is allowed.
• •History of other malignancies at other sites, except effectively treated non-melanoma skin cancers, superficial bladder cancer or carcinoma in situ of the cervix or an effectively treated malignancy that has been in remission for greater than 5 years and is highly likely to have been cured
• •Uncontrolled medical problems (neurological, cardiovascular, gastrointestinal, genitourinary or other illness) considered as unwarranted high risk for investigational new drug treatment
• •Patient is lactating
• •Staging classification of TX or NX or MX
• •Prior adjuvant chemotherapy within 8 weeks prior to the Day 0 visit