Dose-Escalation Study of CG0070 for Bladder Cancer After BCG (Bacillus Calmette-Guerin) Failure
- Conditions
- Carcinoma, Transitional CellBladder Neoplasms
- Interventions
- Biological: Oncolytic adenovirus (serotype 5) - CG0070
- Registration Number
- NCT00109655
- Lead Sponsor
- Cell Genesys
- Brief Summary
The main purpose of this research study is to evaluate the safety and dosing of CG0070.
- Detailed Description
Cohorts of three to six patients will be assigned to receive intravesical (into the bladder) administration of CG0070 either Weekly or Every 4 Weeks for up to a total of 6 doses.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 75
- High grade non-muscle invasive bladder cancer (stages Ta, T1 and/or CIS - carcinoma in situ). High grade being defined as G2 or G3 disease.
- Failure of at least one prior treatment with BCG, defined as evidence of TCC on cystoscopic exam and biopsy or cystoscopic exam and urine cytology at least 6 weeks from last BCG treatment
- ECOG performance status 0-1
- Adequate bone marrow, renal, liver and coagulation function
- Pregnant or nursing
- HIV positive
- Use of anticoagulants such as coumadin or heparin
- History of bleeding disorder
- Active systemic autoimmune disease or chronic immunodeficiency
- Prior gene therapy
- Uncontrolled cystitis, bladder pain, bladder spasms, urinary incontinence, or reduced bladder volume
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Oncolytic adenovirus (serotype 5) - CG0070 -
- Primary Outcome Measures
Name Time Method Maximum-tolerated or maximum feasible dose in single and multidose regimens of CG0070 by intravesical administration Study End
- Secondary Outcome Measures
Name Time Method Assessment of the amount of CG0070 in the urine and blood over time by PCR Study End
Trial Locations
- Locations (10)
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
BCG Oncology
🇺🇸Phoenix, Arizona, United States
Billings Clinic
🇺🇸Billings, Montana, United States
New York Oncology Hematology
🇺🇸Albany, New York, United States
Columbia University
🇺🇸New York, New York, United States
Mary Crowley Medical Research Center
🇺🇸Dallas, Texas, United States
The Fe/Male Health Centre
🇨🇦Oakville, Ontario, Canada
Cancer Centers of the Carolinas
🇺🇸Greenville, South Carolina, United States
Male/Female Health and Research Centre
🇨🇦Barrie, Ontario, Canada