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

• Status: Completed
• Trial end date: 2009-08-11
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to explore a treatment that potentially enhances the delivery of chemotherapy to tumors in participants with superficial bladder cancer. The investigational medication to be studied is an enzyme called ChemophaseTM (recombinant human hyaluronidase, rHuPH20). Chemophase is being specifically developed for use with other anticancer drug to increase the local penetration of the anticancer drug for the treatment of superficial bladder cancer. In this study, Chemophase will be given in combination with mitomycin C directly into the bladder. Mitomycin C is an anti-tumor drug that is commonly used to treat superficial bladder cancer. It is envisioned that Chemophase with mitomycin C may potentially increase the local penetration of mitomycin C into remaining cancer cells following surgery to treat superficial bladder cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Halozyme Therapeutics
• Treatments: Mitomycin; Mitomycins

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.