Compassionate Use of MitoGel in Upper Tract Urothelial Carcinoma
Status:
No longer available
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
The aim of this study is to evaluate the feasibility, safety, and efficacy of MitoGel in the
treatment of UTUC in a human subject with low-grade UTUC which is endoscopically unresectable
or rapidly recurring, and in whom nephrectomy would likely result in the need for permanent
hemodialysis. The study drug would be obtained under the single patient access program
approved by the FDA. The patient would then undergo instillation of MitoGel into the affected
kidney. The catheter would be left indwelling in the ureter and would be externalized. The
ureteral and urethral catheters would remain indwelling for the duration of the 6 treatments,
which would occur twice weekly for 3 weeks or once weekly for 6 weeks. Following the final
instillation, the catheters would be removed. The patient would then undergo ureteroscopic
evaluation at 3 months following the final instillation of MitoGel. The total duration of
study would be 3 months. The total number of study patients is 1.