Study of Immediate Post-Operative Intravesical Instillation of Chemophase® in Patients With Superficial Bladder Cancer — IPOP  

Superficial Bladder Cancer Clinical Trial

Official title: Phase I Safety and Tolerability Study of Immediate Post-Operative Intravesical Instillation of Chemophase® (Recombinant Human Hyaluronidase in Combination With Mitomycin) in Patients With Non-Muscle-Invasive Bladder Cancer

Status Completed

Clinical Trial Summary

The purpose of this research study is to test the safety and tolerability of an experimental drug, Chemophase, a combination of recombinant human hyaluronidase, (an investigational synthetic enzyme also known as rHuPH20), and mitomycin (MMC) in the treatment of superficial bladder cancer when instilled intravesically immediately after TURBT (transurethral resection of bladder tumor).

Clinical Trial Description

Patients will be screened and enrolled prior to undergoing standard of care TURBT for known or suspected Stage Ta, T1 or Tis bladder cancer of any histological grade requiring TURBT and who are believed to be candidates for IPOP intravesical chemotherapy regardless of the need for further intravesical therapy. Within 6 hours after completion of TURBT, patients will be administered a single IPOP intravesical instillation of Chemophase with a one-hour dwell time. At the end of the one-hour dwell time, the patient will be asked to fully void or, if an intravesical catheter has been left in place, the bladder will be fully drained via the catheter. Patients will return at 1 and 2 weeks post instillation for follow up visits for safety and for a cystoscopy at day 85 (per standard of care). Safety and tolerability will be assessed through physical examinations, vital signs, cystoscopy, hematology (CBC), adverse event reporting, and measurements of plasma levels of MMC. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Superficial Bladder Cancer
• Urinary Bladder Neoplasms

• NCT number: NCT00782587
• Study type: Interventional
• Source: Halozyme Therapeutics
• Status: Completed
• Phase: Phase 1
• Start date: October 2008
• Completion date: August 2009