Bladder Cancer
Conditions
Brief summary
The study objective is to evaluate the feasibility of three instillations of immunostimulating gene therapy (AdCD40L) in patients with urinary bladder cancer. Tolerance, toxicity and immunological parameters will be evaluated during and post treatment.
Interventions
GENETICAdCD40L
Adenovirus vector serotype 5, E1/E3 deletion with human CD40L gene driven by RSV promoter
Sponsors
Uppsala University Hospital
Uppsala University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Toxicity | Continously during therapy and at follow up 30d |
Secondary
| Measure | Time frame |
|---|---|
| Inflammation | Continously during treatment and at follow up 30d |
Countries
Sweden
Outcome results
None listed