Safety Study on AdCD40L Gene Therapy for Bladder Cancer

This study has been completed.
Sponsor:
Collaborator:
Uppsala University Hospital
Information provided by:
Uppsala University
ClinicalTrials.gov Identifier:
NCT00891748
First received: April 30, 2009
Last updated: January 15, 2010
Last verified: April 2009
  Purpose

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 Intervention Phase
Bladder Cancer
Genetic: AdCD40L
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/IIa Study of Dose-escalating Intravesical AdCD40L Instillation in Urinary Bladder Carcinoma

Resource links provided by NLM:


Further study details as provided by Uppsala University:

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: 12
Study Start Date: November 2006
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00891748

Locations
Sweden
Uppsala University Hospital
Uppsala, Sweden, 75185
Sponsors and Collaborators
Uppsala University
Uppsala University Hospital
Investigators
Principal Investigator: Per-Uno Malmstrom, MD PhD Uppsala University Hospital, Uppsala, Sweden
  More Information

No publications provided

Responsible Party: Thomas H Totterman, Uppsala University
ClinicalTrials.gov Identifier: NCT00891748     History of Changes
Other Study ID Numbers: 001:CD40L, 2006-000985-34
Study First Received: April 30, 2009
Last Updated: January 15, 2010
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 28, 2014