Safety Study on AdCD40L Gene Therapy for Bladder Cancer

NCT00891748 | Completed Phase 1

• 2 other identifiers: 001:CD40L2006-000985-34
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Toxicity

  Continously during therapy and at follow up 30d

Secondary Outcomes (1)

• Inflammation

  Continously during treatment and at follow up 30d

Study Arms (1)

AdCD40L

EXPERIMENTAL

Adenovirus vector serotype 5, E1/E3 deletion with human CD40L gene driven by RSV promoter.

Genetic: AdCD40L

Interventions

AdCD40L GENETIC

Adenovirus vector serotype 5, E1/E3 deletion with human CD40L gene driven by RSV promoter

AdCD40L

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven diagnosis of transitional cell carcinoma of the bladder
• ECOG 0-2
• years of age or older
• signed informed consent
• for the Phase I part: patient scheduled for cystectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Uppsala University: lead
• Uppsala University Hospital: collaborator

Study Sites (1)

Uppsala University Hospital

Uppsala, 75185, Sweden

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Per-Uno Malmstrom, MD PhD

  Uppsala University Hospital, Uppsala, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 30, 2009
• First Posted: May 1, 2009
• Study Start: November 1, 2006
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: January 18, 2010

Record last verified: 2009-04

Locations

SE (1)