Safety Study on AdCD40L Gene Therapy for Bladder Cancer

Phase 1

Completed

• Conditions: Bladder Cancer
• Interventions: Genetic: AdCD40L

• Registration Number: NCT00891748
• Lead Sponsor: Uppsala University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Status Verified: 2009-04
• Study First Submitted: 2009-04-30
• Study First Submitted QC: 2009-04-30
• Study First Posted: 2009-05-01
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Last Update Submitted: 2010-01-15
• Last Update Posted: 2010-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AdCD40L	AdCD40L	Adenovirus vector serotype 5, E1/E3 deletion with human CD40L gene driven by RSV promoter.

Primary Outcome Measures

Name	Time	Method
Toxicity	Continously during therapy and at follow up 30d

Secondary Outcome Measures

Name	Time	Method
Inflammation	Continously during treatment and at follow up 30d

Trial Locations

Locations (1)

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden