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

• Conditions: rinary bladder cancer is an attractive target for immunostimulating gene therapy because it is sensitive for immunotherapy as demonstrated by the life-prolonging effect of bacillus Calmette-Guérin (BCG) instillations. Phase I: Patients with infiltrative cancer of the urinary bladder and scheduled for cystectomy.Phase IIa: Patients with non-infiltrative cancer of the urinary bladder, stages Ta and scheduled for resection

• Registration Number: EUCTR2006-000985-34-SE
• Lead Sponsor: Clinical Immunology Division

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-12
• Last Update Posted: 11 February 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.ECOG 0-2 (Appendix 1.4).
2.Male or females, 18 years of age or older.
3.Signed informed consent must be obtained.
Patients in the phase I part of the study should also meet the criteria:
4.Histological proven diagnosis of transitional cell carcinoma of the bladder, scheduled for cystectomy.

Patients in the phase IIa part of the study should also meet the following criteria:
5.Histological proven diagnosis of Ta, recurrent transitional cell carcinoma of the bladder.
6.Evaluable disease confirmed by positive biopsy histology

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

7. Woman of childbearing potential (fertile woman).
8.Other malignancy within 5 years of study, except for non-melanoma skin cancer.
9.Metastatic disease.
10.Previous exposure to any intravesical therapy for bladder cancer: within 3 months for chemotherapy and within 6 months for BCG therapy.
11.Previous pelvic radiation or treatment with any cytotoxic, immunologic or chemotherapeutic agent for non-malignant conditions within 5 years of study.
12.Clinically abnormal hepatic, renal or bone marrow function, or coagulation disorders in the opinion of the investigator.
13.Chronic urinary tract infections.
14.Serious infection or G.U. surgery within 1 month of study requiring more than 3 days of hospital care.
15.Vesical capacity <150 mL and/or vesical obstruction with residual >100 mL after spontaneous voiding.
16.Previous exposure to any experimental drug within 3 months from enrolment.
17.Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures.
18.Patients who presently have transitional cell carcinoma of the upper tract and/or disease
19.Patients with systemic autoimmune disease.
20.Patients that do not consent to that tissue and blood samples are stored in a biobank.
21.Treatment with systemically administered corticosteroids and NSAID within 4 weeks prior to first study treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified