Safety and Efficacy of CG0070 Oncolytic Virus Regimen in Patients With High Grade Non-Muscle Invasive Bladder Cancer

Inclusion Criteria

• •• Patients must have pathologically confirmed high grade disease (HG), as defined by the 2004 WHO classification system
• •* Patients must have no evidence of muscle invasive disease
• •* Patient must fall under one of the following criteria:
• •1. Patients who were first enrolled in the BOND protocol but have failed to achieve a complete response or have relapsed following a complete response at 3 months after receiving control treatments
• •2. OR patients who were first enrolled in the BOND protocol but have relapsed following a complete response lasting over a year after receiving CG0070 treatments
• •3. OR patients who have Ta/T1 high grade, refused cystectomy and are CG0070 naïve
• •4. OR patients from the exBOND protocol who experienced a tumor relapse with no disease progression after sustaining 12 months or longer complete response duration
• •* For Cis patients or Cis with Ta and/or T1 only:
• •1. Tumor must be considered unresectable or with residual disease.
• •2. Patients must be declared as medically unfit for cystectomy.
• •3. No disease progression from disease status at the beginning of the BOND trial.
• •* For Ta/T1 HG Patients:
• •1. They must have also received at least one prior course of BCG therapy per the recommended schedules. Patients can have either failed BCG induction therapy within a six-month period or have been successfully treated with BCG, but subsequently found to have recurrence. The standard course of intravesical BCG therapy must include at least six weekly treatments (allowable range of instillations per course is 4-9) within a six-month period
• •2. They must have received 2 or more intravesical chemotherapy regimens other than BCG
• •3. They must have relapsed within 6 months of their last treatment
• •* 18 years of age or older
• •* Radical cystectomy has been declined by the patient in a signed special section of the informed consent, whereby there is a clear explanation by the investigator to the subject that a delay of cystectomy may increase his/her chance of disease progression, the results of which may lead to serious and life threatening consequences.
• •* Patients must be able to enter into the study within five weeks of their most recent diagnostic procedure, which is usually a diagnostic biopsy, a transurethral resection of bladder tumor (TURBT) procedure or other diagnostic scanning such as CT and PET procedures.
• •* Histopathologically confirmed, transitional cell (urothelial) carcinoma. Urothelial tumors with mixed histology (but with \<50% variant) are eligible.
• •* Eastern Cooperative Oncology Group (ECOG) performance status \<2.
• •* Not pregnant or lactating
• •* Patients with child bearing potential must agree to use adequate contraception
• •* Agree to study specific informed consent and HIPAA authorization for release of personal health information
• •* Adequate baseline CBC, renal and hepatic function. Parameters described as .WBC\>3000 cells/mm3, ANC\>1,000 cells/mm3, hemoglobin\>10g/dL, and platelet count \>100,000 cells/mm3
• •* Adequate renal function: serum creatinine \<2.0mg/dL
• •* Bilirubin, AST and ALT not more than 2 x Upper Limits of Normal
• •* PT/INR, PTT, and fibrinogen within institutional normal limits
• •* Absolute lymphocyte count ≥ 800/μL before the first dose of CG0070