Status:
COMPLETED
Safety Study on AdCD40L Gene Therapy for Bladder Cancer
Lead Sponsor:
Uppsala University
Collaborating Sponsors:
Uppsala University Hospital
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 par...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00891748
Start Date
November 1 2006
End Date
October 1 2009
Last Update
January 18 2010
Active Locations (1)
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1
Uppsala University Hospital
Uppsala, Sweden, 75185