A Study of Mitomycin C in Combination with Synergo® Radiofrequency-Induced Hyperthermia to Treat Non-Muscle Invasive Bladder Cancer

Full Title

A Multicenter, Single-Arm Study Evaluating the Efficacy of Synergo® Radiofrequency-Induced Thermochemotherapy Effect (RITE) with Mitomycin C (Synergo® RITE + MMC) in CIS Non-Muscle Invasive Bladder Cancer (NMIBC) Bacillus Calmette-Guérin (BCG)-Unresponsive Patients with or without papillary NMIBC

Purpose

Applying heat while delivering chemotherapy has been shown to enhance the anticancer effects of many chemotherapy drugs. In this study, researchers are assessing the effectiveness of a system called Synergo RITE (“radiofrequency-induced thermochemotherapy effect”) in patients with bladder cancer that has not invaded the muscle wall and persists despite prior BCG treatment.

The Synergo system uses microwaves to deliver controlled heat directly to the walls of the bladder. In addition, the system infuses a chemotherapy drug called mitomycin C into the bladder through a catheter inserted through the urethra. It is hoped that this treatment will kill cancer cells, delay cancer recurrence, and preserve the bladder.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have non-muscle-invasive bladder cancer that persists or came back despite prior treatment with Bacillus Calmette-Guerin (a form of immunotherapy).
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Guido Dalbagni at 646-422-4394.

Protocol

19-171

Phase

III

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators