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
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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and Tolerability of immediate post-operative instillation of Chemophase.
Day 1 instillation, and weeks 1, 2, and 12
Donald Lamm, M.D.
BCG Oncology, PC
United States: Food and Drug Administration
|Advanced Urology Medical Center||Anaheim, California 92801|
|Advanced Research Institute, Inc.||New Port Richey, Florida 34652|
|MedResearch||La Mesa, California 91942|
|BCG Oncology, PC||Phoenix, Arizona 85032|
|Malcolm Randall Veterans Administration||Gainesville, Florida 32608|