Clinical trial · Interventional
Safety Study on AdCD40L Gene Therapy for Bladder Cancer
A Phase I/IIa Study of Dose-escalating Intravesical AdCD40L Instillation in Urinary Bladder Carcinoma
NCT00891748CI-TRIAL-00003036completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AdCD40L | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AdCD40L
- description
- Adenovirus vector serotype 5, E1/E3 deletion with human CD40L gene driven by RSV promoter.
- interventionNames
- Genetic: AdCD40L
Primary outcomes (1)
- measure
- Toxicity
- timeFrame
- Continously during therapy and at follow up 30d
Secondary outcomes (1)
- measure
- Inflammation
- timeFrame
- Continously during treatment and at follow up 30d
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.