Carcinoma, Transitional Cell Clinical Trial
Official title:
A Phase 1 Dose-Escalation Trial of Intravesical CG0070 for Superficial Transitional Cell Carcinoma of the Bladder After Bacillus Calmette-Guerin Failure
Verified date | October 2008 |
Source | Cell Genesys |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The main purpose of this research study is to evaluate the safety and dosing of CG0070.
Status | Active, not recruiting |
Enrollment | 75 |
Est. completion date | September 2010 |
Est. primary completion date | October 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Male/Female Health and Research Centre | Barrie | Ontario |
Canada | The Fe/Male Health Centre | Oakville | Ontario |
United States | New York Oncology Hematology | Albany | New York |
United States | Billings Clinic | Billings | Montana |
United States | Mary Crowley Medical Research Center | Dallas | Texas |
United States | Cancer Centers of the Carolinas | Greenville | South Carolina |
United States | Baylor College of Medicine | Houston | Texas |
United States | Columbia University | New York | New York |
United States | BCG Oncology | Phoenix | Arizona |
United States | UCSF Comprehensive Cancer Center | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Cell Genesys |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum-tolerated or maximum feasible dose in single and multidose regimens of CG0070 by intravesical administration | Study End | Yes | |
Secondary | Assessment of the amount of CG0070 in the urine and blood over time by PCR | Study End | Yes |
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