Safety Study of Recombinant Human Hyaluronidase (Chemophase) in Combination With Mitomycin in Participants With Superficial Bladder Cancer
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.
Timeline
- Start
- 2006-03-30
- Primary completion
- 2009-08-11
- Completion
- 2009-08-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mitomycin C | Other / unclassified | 40 mg | Other |
| Subject | rHuPH20 | Protein / enzyme biologic | 20000 iu | Other |
| Subject | rHuPH20 | Protein / enzyme biologic | 60000 iu | Other |
| Subject | rHuPH20 | Protein / enzyme biologic | 200000 iu | Other |
| Subject | rHuPH20 | Protein / enzyme biologic | 400000 iu | Other |
| Subject | rHuPH20 | Protein / enzyme biologic | 800000 iu | Other |