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