Safety Study of Recombinant Human Hyaluronidase (Chemophase) in Combination With Mitomycin in Participants With Superficial Bladder Cancer

Inclusion Criteria

• Participants with initial presentation or recurrence of Stage Ta, T1 or Tis, any grade, bladder cancer after transurethral resection of bladder tumor (TURBT).
• TURBT within 42 days prior to Day 1/Week 1
• Karnofsky Performance Status greater than or equal to 80%
• Life expectancy at least 3 years
• 18 years or older
• A negative pregnancy test (if female of child-bearing potential)
• Acceptable liver function within 7 days defined as: bilirubin less than or equal to 1.5 times upper limit of normal, and aspartate aminotransferase (AST) Glutamic-oxalacetic transaminase (SGOT), alanine aminotransferase (ALT), glutamic-pyruvic transaminase (SGPT), and alkaline phosphatase <= 2.5 times upper limit of normal
• Acceptable renal function within 7 days defined as: serum creatinine less than or equal to 1.5 times upper limit of normal, or calculated creatinine clearance greater than or equal to 40 milliliter (mL)/minute/1.73 meter^2
• Acceptable hematologic status within 7 days defined as: absolute neutrophil count (ANC) greater than or equal to 2,500 cells/millimeter^3, platelet count greater than or equal to 150,000/millileter^3, and hemoglobin greater than or equal to 10.0 grams/deciliter.
• Urinalysis showing no clinically significant abnormalities except those attributable to bladder cancer.
• For men and women of child-producing potential, agreement to use an effective contraceptive method during the treatment period of the study.
• Signed, written Institutional Review Board (IRB)-approved informed consent

Exclusion Criteria

• History or previous diagnosis of bladder fibrosis
• Total bladder capacity estimated at cystoscopy to be less than 150 mL
• Urinary incontinence of a severity that would compromise the ability of the participant to retain the study drug intravesical instillation for two hours.
• Severe irritative voiding symptoms such as urgency, frequency, or nocturia
• Known other malignant disease except squamous or basal cell skin cancer unless the malignancy has been in complete remission off therapy for at least 5 years.
• Major surgery, other than TURBT and diagnostic surgery, within 28 days prior to Day 1/Week 1.
• Active, uncontrolled bacterial, viral, or fungal infections, including urinary tract infection.
• Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within one month prior to Day 1/Week 1 on study (two months for nitrosureas 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 human immunodeficiency virus (HIV)
• Known active infection with hepatitis B or hepatitis C
• 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 a hypersensitivity or idiosyncratic reaction to, or other contraindication to, mitomycin.
• Known allergy to bee or vespid venom
• Known coagulation disorder or bleeding tendency
• Treatment with heparin or anticipation of heparin treatment during the treatment period in this study.
• Unwillingness or inability to comply with procedures required in this protocol.