Safety Study on AdCD40L Gene Therapy for Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00891748
• Other study ID #: 001:CD40L
• Secondary ID: 2006-000985-34
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 30, 2009
• Last updated: January 15, 2010
• Start date: November 2006
• Est. completion date: October 2009

Study information

• Verified date: April 2009
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Genetic:
• AdCD40L
Adenovirus vector serotype 5, E1/E3 deletion with human CD40L gene driven by RSV promoter

Locations

Country	Name	City	State
Sweden	Uppsala University Hospital	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University	Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity		Continously during therapy and at follow up 30d	Yes
Secondary	Inflammation		Continously during treatment and at follow up 30d	Yes