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).
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
40 mg mitomycin with 800,000 U rHuPH20 total volume of 40 mL instilled
BCG Oncology, PC
Phoenix, Arizona, United States
Advanced Urology Medical Center
Anaheim, California, United States
Medresearch
La Mesa, California, United States
Malcolm Randall Veterans Administration
Gainesville, Florida, United States
Safety and Tolerability of immediate post-operative instillation of Chemophase.
Time frame: Day 1 instillation, and weeks 1, 2, and 12
Assess plasma levels of mitomycin (MMC) after IPOP intravesical instillation.
Time frame: Hours 1, 2 and 3 post-instillation
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Advanced Research Institute, Inc.
New Port Richey, Florida, United States