Bladder Cancer Clinical Trial
Dose-Escalation Study of CG0070 for Bladder Cancer After BCG (Bacillus Calmette-Guerin) Failure
Summary
The main purpose of this research study is to evaluate the safety and dosing of CG0070.
Full 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 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
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There are 10 Locations for this study
Phoenix Arizona, 85032, United States
San Francisco California, 94143, United States
Billings Montana, 59107, United States
Albany New York, 12208, United States
New York New York, 10032, United States
Greenville South Carolina, 29605, United States
Dallas Texas, 75246, United States
Houston Texas, 77030, United States
Barrie Ontario, L4M 7, Canada
Oakville Ontario, L6H 3, Canada
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