A Phase III Study of MitoGel for Upper Urinary Tract Urothelial Carcinoma

Full Title

A Phase 3 Multicenter Trial Evaluating The Efficacy and Safety of MitoGel(TM) (UGN-101) on Ablation of Upper Urinary Tract Urothelial Carcinoma

Purpose

People with upper urinary tract urothelial carcinoma (UTUC, a type of cancer that can grow inside the kidney or the ureter) are usually treated with surgery to remove the kidney and ureter. For patients with low-grade cancers, this approach may be more aggressive than needed. In this study, researchers are evaluating a new type of treatment for patients with low-grade UTUC that does not include surgery, called MitoGel. MitoGel is a combination of mitomycin C (MMC), a chemotherapy drug, and a new kind of gel called TC-3.

Normally, giving MMC into the kidney through the ureter does not work for patients with UTUC, because it is flushed out of the body in the urine before it can dwell long enough to kill cancer cells. By combining MMC with this new kind of gel, the MMC will be able to stay in the urinary system for several hours, increasing the chance of killing cancer cells there. MMC is used to treat patients with stomach, pancreatic, and bladder cancers; its use with TC-3 gel is considered investigational.

MitoGel is administered into the urinary tract through a catheter that is temporarily inserted by the doctor for each treatment.

Eligibility

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

  • Patients must have low-grade noninvasive UTUC that is newly diagnosed or has come back.
  • Patients may not have received BCG therapy within 6 months of entering the study.
  • In addition to patients with good physical function, this study is also open to those who are capable of only limited self-care and are confined to bed or chair for more than half of their normal waking hours.
  • 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 or Dr. Jonathan Coleman at 646-422-4432.

Protocol

18-166

Phase

III

Disease Status

Newly Diagnosed

Investigator

Coleman, Jonathan, MD

Co-Investigators