We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Safety Study on AdCD40L Gene Therapy for Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00891748
Recruitment Status : Completed
First Posted : May 1, 2009
Last Update Posted : January 18, 2010
Uppsala University Hospital
Information provided by:
Uppsala University

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 parameters will be evaluated during and post treatment.

Condition or disease Intervention/treatment Phase
Bladder Cancer Genetic: AdCD40L Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/IIa Study of Dose-escalating Intravesical AdCD40L Instillation in Urinary Bladder Carcinoma
Study Start Date : November 2006
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: AdCD40L
Adenovirus vector serotype 5, E1/E3 deletion with human CD40L gene driven by RSV promoter.
Genetic: AdCD40L
Adenovirus vector serotype 5, E1/E3 deletion with human CD40L gene driven by RSV promoter

Primary Outcome Measures :
  1. Toxicity [ Time Frame: Continously during therapy and at follow up 30d ]

Secondary Outcome Measures :
  1. Inflammation [ Time Frame: Continously during treatment and at follow up 30d ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00891748

Layout table for location information
Uppsala University Hospital
Uppsala, Sweden, 75185
Sponsors and Collaborators
Uppsala University
Uppsala University Hospital
Layout table for investigator information
Principal Investigator: Per-Uno Malmstrom, MD PhD Uppsala University Hospital, Uppsala, Sweden
Layout table for additonal information
Responsible Party: Thomas H Totterman, Uppsala University
ClinicalTrials.gov Identifier: NCT00891748    
Other Study ID Numbers: 001:CD40L
First Posted: May 1, 2009    Key Record Dates
Last Update Posted: January 18, 2010
Last Verified: April 2009
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases