Trial Information

Summary: The main purpose of this research study is to evaluate the safety and dosing of an investigational gene transfer agent called CG0070 and to see if it has an effect on superficial bladder cancer that does not respond to prior BCG (bacillus Calmette-Guerin) treatment.

If you qualify for the study, you will be assigned to receive CG0070 through catheter placement (small tube) in the bladder at either one of 2 schedules: weekly or every 4 weeks for up to a total of 6 doses. You will be required to come into the clinic for study visits for approximately 2 years and then you will be monitored for any long-term effects of being treated with CG0070 (for up to 15 years after your first dose of CG0070).

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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Trial listings updated: June 1, 2008 at 6:32:48 AM