Safety Study on AdCD40L Gene Therapy for Bladder Cancer

Inclusion Criteria: * Histologically proven diagnosis of transitional cell carcinoma of the bladder * ECOG 0-2 * 18 years of age or older * signed informed consent * for the Phase I part: patient scheduled for cystectomy Exclusion Criteria: * Woman of childbearing potential (fertile woman) * Other malignancy within 5 years of study, except for non-melanoma skin cancer * Metastatic disease * Previous exposure to any intravesical therapy for bladder cancer: within 3 months for chemotherapy and within 6 months for BCG therapy. * Previous pelvic radiation or treatment with any cytotoxic, immunologic or chemotherapeutic agent for non-malignant conditions within 5 years of study. * Clinically abnormal hepatic, renal or bone marrow function, or coagulation disorders in the opinion of the investigator. * Chronic urinary tract infections. * Serous infection of G.U. surgery, except for bladder cancer, within 1 month of study requiring more than 3 days of hospital care. * Vesical capacity \<150mL and/or vesical obstruction with residual \>150 mL after spontaneous voiding. * Previous exposure to any experimental drug within 3 months from enrolment. * Any significant medical or psychiatric illness that would prevent the patient from giving informed consent of from following the study procedures. * Patients who presently have urothelial cell carcinoma of the upper G.U. tract * Patients with systemic autoimmune disease * Patients that do not consent to that tissue and blood samples are stored in a biobank * Treatment with systemically administered corticosteroids and NSAID within 4 weeks prior to first study treatment