A Phase I/IIa Study of Dose-escalating Intravesical AdCD40L Instillation in Urinary Bladder Carcinoma
- 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
- 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
- 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