Study of Immediate Post-Operative Intravesical Instillation of Chemophase® in Patients With Superficial Bladder Cancer

Exclusion Criteria

• •Large resected area (estimated total area \> 50 cm²) or suspected deep resection, even in the absence of signs of perforation beyond the muscularis propria or ongoing significant bleeding.
• •Known or suspected bladder perforation during TURBT.
• •Failure to completely resect all cancerous lesions or suspected presence of muscle-invasive cancer (Stage T2 or higher).
• •Previous diagnosis or current presence of bladder fibrosis/contracture, or total bladder capacity estimated at cystoscopy or by other means to be \< 150 mL.
• •Urinary incontinence or severe irritative voiding symptoms such as urgency, frequency, or nocturia of a severity that would compromise the ability of the patient to retain the study drug intravesical instillation for one hour.
• •Bladder cancer recurrence less than 3 months after a previous TURBT.
• •Major surgery, other than TURBT or diagnostic surgery, within 28 days prior to Day 1/Week 1.
• •Known active, uncontrolled bacterial, viral, or fungal infections, including urinary tract infection.
• •Any intravesical therapy within 3 months prior to Week 1/Day 1.
• •Systemic therapy including radiation therapy, surgery, chemotherapy, or investigational therapy within one month prior to Day 1/Week 1 (two months for nitrosoureas or MMC), unless given as standard treatment for bladder cancer and provided that patient is free of all treatment-related toxicities as of Day 1/Week 1.
• •Known infection with HIV.
• •Known active infection with hepatitis B or hepatitis C virus.
• •Serious disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor (Halozyme).
• •History of hypersensitivity or idiosyncratic reaction to, or other contraindication to, MMC.
• •Known allergy to bee or vespid venom.
• •Known coagulation disorder or bleeding tendency.
• •Ongoing treatment with heparin or other anticoagulation therapy, or anticipation of such therapy during the treatment period in this study.
• •Unwillingness or inability to comply with procedures required in this protocol.