Efficacy Study of Recombinant Adenovirus for Non Muscle Invasive Bladder Cancer

Exclusion Criteria

• •1. Previous systemic chemotherapy or radiation for bladder cancer. Note: Prior immunotherapy or intravesical (administered within the bladder) chemotherapy for superficial disease is acceptable
• •2. No bladder cancer residual disease, such as patients that are rendered disease free by TURBT
• •3. History of anaphylactic reaction following exposure to humanized or human therapeutic monoclonal antibodies, hypersensitivity to GM-CSF or yeast derived products, clinically meaningful allergic reactions or any known hypersensitivity or prior reaction to any of the formulation excipients in the study drugs.
• •4. Known infection with HIV, HBV or HCV.
• •5. Anticipated use of chemotherapy, radiotherapy, or other immunotherapy not specified in the study protocol while on study
• •6. Any underlying medical condition that, in the Investigator's opinion, will make the administration of study vaccine hazardous to the patient, would obscure the interpretation of adverse events, or surgical resection. Anticipated use of chemotherapy, radiotherapy, or other immunotherapy not specified in the study protocol while on study
• •7. Systemic treatment on any investigational clinical trial within 28 days prior to registration.
• •8. Concurrent treatment with immunosuppressive or immunomodulatory agents, including any systemic steroid (exception: inhaled or topically applied steroids, and acute and chronic standard dose NSAIDs, are permitted). Use of a short course (i.e., ≤ 1 day) of a glucocorticoid is acceptable to prevent a reaction to the IV contrast used for CT scans.
• •9. Immunosuppressive therapy, including: cyclosporine, antithymocyte globulin, or tacrolimus within 3 months of study entry.
• •10. History of prior experimental cancer vaccine treatment (e.g., dendritic cell therapy, heat shock vaccine)
• •11. History of partial cystectomy in the setting of bladder cancer primary tumor.
• •12. History of anaphylactic reaction following exposure to humanized or human therapeutic monoclonal antibodies, hypersensitivity to GM-CSF or yeast derived products, clinically meaningful allergic reactions or any known hypersensitivity or prior reaction to any of the formulation excipients in the study drugs.
• •13. History of stage III or greater cancer, excluding urothelial cancer. Basal or squamous cell skin cancers must have been adequately treated and the subject must be disease-free at the time of registration. Subjects with a history of stage I or II cancer, must have been adequately treated and have been disease-free for ≥ 3 years at the time of registration.
• •14. Concomitant active autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, autoimmune thyroid disease, uveitis)
• •15. Progressive viral or bacterial infection
• •16. All infections must be resolved and the patient must remain afebrile for seven days without antibiotics prior to being placed on study
• •17. Any underlying medical condition that, in the Investigator's opinion, will make the administration of study vaccine hazardous to the patient, would obscure the interpretation of adverse events, or not permit adequate surgical resection.
• •18. Unwilling or unable to comply with the protocol or cooperate fully with the investigator and site personnel