Clinical trial NCT00318643 (phase 1/phase 2, status: completed)
Conditions: bladder cancer
ICD codes: D30.3, C67.5, C67.9, C79.11, C67.0, C67.1, D41.4
Drugs: mitomycin c, chemophase
SMILES: CO[C@]12[C@H]3N[C@H]3CN1C1=C([C@H]2COC(N)=O)C(=O)C(N)=C(C)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Patients 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 AST (SGOT), ALT (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 mL/min/1.73 m2

          -  Acceptable hematologic status within 7 days defined as: absolute neutrophil count
             (ANC) greater than or equal to 2,500 cells/mm3, platelet count greater than or equal
             to 150,000/mm3, and hemoglobin greater than or equal to 10.0 g/dL.

          -  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 patient 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 (1) month prior to Day 1/Week 1 on study (two [2] 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.