Safety Study on AdCD40L Gene Therapy for Bladder Cancer
Primary Purpose
Bladder Cancer
Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
AdCD40L
Sponsored by
About this trial
This is an interventional treatment trial for Bladder Cancer
Eligibility 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
Sites / Locations
- Uppsala University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AdCD40L
Arm Description
Adenovirus vector serotype 5, E1/E3 deletion with human CD40L gene driven by RSV promoter.
Outcomes
Primary Outcome Measures
Toxicity
Secondary Outcome Measures
Inflammation
Full Information
NCT ID
NCT00891748
First Posted
April 30, 2009
Last Updated
January 15, 2010
Sponsor
Uppsala University
Collaborators
Uppsala University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00891748
Brief Title
Safety Study on AdCD40L Gene Therapy for Bladder Cancer
Official Title
A Phase I/IIa Study of Dose-escalating Intravesical AdCD40L Instillation in Urinary Bladder Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Uppsala University
Collaborators
Uppsala University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AdCD40L
Arm Type
Experimental
Arm Description
Adenovirus vector serotype 5, E1/E3 deletion with human CD40L gene driven by RSV promoter.
Intervention Type
Genetic
Intervention Name(s)
AdCD40L
Intervention Description
Adenovirus vector serotype 5, E1/E3 deletion with human CD40L gene driven by RSV promoter
Primary Outcome Measure Information:
Title
Toxicity
Time Frame
Continously during therapy and at follow up 30d
Secondary Outcome Measure Information:
Title
Inflammation
Time Frame
Continously during treatment and at follow up 30d
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per-Uno Malmstrom, MD PhD
Organizational Affiliation
Uppsala University Hospital, Uppsala, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Safety Study on AdCD40L Gene Therapy for Bladder Cancer
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