OLYMPUS: Safety and Effectiveness of a Treament (MitoGel™) for Cancer of the Upper Urinary Tract

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Age:
18 years and older
Gender:
Any
Healthy Volunteers:
No
Keywords:
UTUC, urothelial cancer, non-invasive, Upper Urinary Tract Urothelial Carcinoma, VesiGel, MitoGel, Transitional Cell Carcinoma
Type:
Drug Study
Target:
5 Participants
Description
The purpose of this study is to test the safety and effectiveness of an experimental medicine MitoGel™ in the treatment of upper urinary tract cancer.

MitoGel™ is a combination of “Mitomycin C” and “TC-3 gel”. “Mitomycin C” is an FDA approved cancer treatment. “TC-3 gel” is a carrier gel used to deliver medicine into the upper urinary tract.

A catheter is used to deliver MitoGel™ to the upper urinary tract where the cancer is located. There, MitoGel™ warms to human body temperature and turns into a gel.

As the gel dissolves it releases the Mitomycin C cancer treatment. This allows for several hours of continuous chemotherapy treatment in a localized area. This is believed to be an improvement on current upper urinary tract cancer chemotherapy treatments.
This study requires
-Six weekly MitoGel™ installations (Catheter will be used to deliver MitoGel™ to upper urinary tract.)
- Ongoing Urology related exams and blood work
- Have periodic cytology (test urine cells)
- Have periodic scoping (test used to visualize upper urinary tract)
- Your doctor may continue monthly maintenance instillation treatments for 12 months

A more detailed list of requirements can be found in the consent form below.
Who can participate?
To be in this Study, you must be at least 18 years of age and have been diagnosed with a low grade, upper urinary tract urothelial cancer.

A more detailed inclusion and exclusion criteria can be found in the consent form below.
Benefits and risks of participating
A detailed list of potential benefits and risks can be found in the consent form below.
Resources
PDF Docs
Informed consent form
Schedule
Study duration and period
We expect that you will be in this research study for approximately 14 months (a little over one year).
Location
Urology Clinic
4860 Y Street
suite 2200
Sacramento, CA 95817
Contact
Mark William Alger