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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
Sponsor:
Collaborator:
Uppsala University Hospital
Information provided by:
Uppsala University

Tracking Information
First Submitted Date  ICMJE April 30, 2009
First Posted Date  ICMJE May 1, 2009
Last Update Posted Date January 18, 2010
Study Start Date  ICMJE November 2006
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2009)
Toxicity [ Time Frame: Continously during therapy and at follow up 30d ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2009)
Inflammation [ Time Frame: Continously during treatment and at follow up 30d ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study on AdCD40L Gene Therapy for Bladder Cancer
Official Title  ICMJE A Phase I/IIa Study of Dose-escalating Intravesical AdCD40L Instillation in Urinary Bladder Carcinoma
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bladder Cancer
Intervention  ICMJE Genetic: AdCD40L
Adenovirus vector serotype 5, E1/E3 deletion with human CD40L gene driven by RSV promoter
Study Arms  ICMJE Experimental: AdCD40L
Adenovirus vector serotype 5, E1/E3 deletion with human CD40L gene driven by RSV promoter.
Intervention: Genetic: AdCD40L
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: April 30, 2009)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00891748
Other Study ID Numbers  ICMJE 001:CD40L
2006-000985-34
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thomas H Totterman, Uppsala University
Study Sponsor  ICMJE Uppsala University
Collaborators  ICMJE Uppsala University Hospital
Investigators  ICMJE
Principal Investigator: Per-Uno Malmstrom, MD PhD Uppsala University Hospital, Uppsala, Sweden
PRS Account Uppsala University
Verification Date April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP