Safety Study on AdCD40L Gene Therapy for Bladder Cancer
This study has been completed.
Uppsala University Hospital
Information provided by:
First received: April 30, 2009
Last updated: January 15, 2010
Last verified: April 2009
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.
||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase I/IIa Study of Dose-escalating Intravesical AdCD40L Instillation in Urinary Bladder Carcinoma
Primary Outcome Measures:
- Toxicity [ Time Frame: Continously during therapy and at follow up 30d ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Inflammation [ Time Frame: Continously during treatment and at follow up 30d ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2009 (Final data collection date for primary outcome measure)
Adenovirus vector serotype 5, E1/E3 deletion with human CD40L gene driven by RSV promoter.
Adenovirus vector serotype 5, E1/E3 deletion with human CD40L gene driven by RSV promoter
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00891748
|Uppsala University Hospital
|Uppsala, Sweden, 75185 |
Uppsala University Hospital
||Per-Uno Malmstrom, MD PhD
||Uppsala University Hospital, Uppsala, Sweden
No publications provided
||Thomas H Totterman, Uppsala University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 30, 2009
||January 15, 2010
||Sweden: Medical Products Agency
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 16, 2014
Urinary Bladder Neoplasms
Neoplasms by Site
Urinary Bladder Diseases