Status:
UNKNOWN
Dose-Escalation Study of CG0070 for Bladder Cancer After BCG (Bacillus Calmette-Guerin) Failure
Lead Sponsor:
Cell Genesys
Conditions:
Carcinoma, Transitional Cell
Bladder Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2010
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00109655
Start Date
April 1 2005
End Date
September 1 2010
Last Update
October 3 2008
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
BCG Oncology
Phoenix, Arizona, United States, 85032
2
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94143
3
Billings Clinic
Billings, Montana, United States, 59107
4
New York Oncology Hematology
Albany, New York, United States, 12208