Safety Study on AdCD40L Gene Therapy for Bladder Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Bladder Cancer

Intervention / Treatment
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* Genetic: AdCD40L


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AdCD40L<br>Adenovirus vector serotype 5, E1/E3 deletion with human CD40L gene driven by RSV promoter. | Genetic: AdCD40L<br>* Adenovirus vector serotype 5, E1/E3 deletion with human CD40L gene driven by RSV promoter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  | Continously during therapy and at follow up 30d | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation |  | Continously during treatment and at follow up 30d |