Safety Study of Recombinant Human Hyaluronidase (Chemophase) in Combination With Mitomycin in Participants With Superficial Bladder Cancer
Bladder Cancer
About this trial
This is an interventional prevention trial for Bladder Cancer focused on measuring Non-invasive bladder cancer, Chemophase, Intravesical administration, Superficial Bladder Cancer
Eligibility Criteria
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.
Sites / Locations
- BCG Oncology
- MedResearch
- Malcolm Randall Veterans Administration Urology Section (112-C)
- Advanced Research Institute
- James A. Haley Veterans Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
Cohort 1: MMC plus Chemophase 20,000 U
Cohort 2: MMC plus Chemophase 60,000 U
Cohort 3: MMC plus Chemophase 200,000 U
Cohort 4: MMC plus Chemophase 400,000 U
Cohort 5: MMC plus Chemophase 800,000 U
Participants will receive 40 milligrams (mg) MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 20,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
Participants will receive 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 60,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
Participants will receive 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 200,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
Participants will receive 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 400,000 U Chemophase intravesically once weekly from Weeks 2 through 6.
Participants will receive 40 mg MMC intravesically on Day 1 of Week 1 followed by a combination of 40 mg MMC and 800,000 U Chemophase intravesically once weekly from Weeks 2 through 6.