A Study to Evaluate the Effectiveness and Safety of UGN-101 in Patients with Recurrent Upper Urinary Tract Urothelial Carcinoma

Overview

About this study

The purpose of this study is to evaluate the effectiveness and safety of UGN-101 administered to the upper urinary tract (UUT) in patients who were treated in Trial TC-UT-03, found to be a complete response (CR) at the Primary Disease Evaluation (PDE) 1 Visit, and are subsequently found to have a documented recurrence of low grade (LG) upper tract urothelial carcinoma (UTUC) at follow up (FU).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

Inclusion Criteria:

  • Patients with recurrent LG UTUC who were found to be CR at the PDE 1 Visit (in Trial TC-UT-03). 
  • Biopsy taken from 1 or more tumors located in the UUT shows LG urothelial carcinoma (up to 2 months before Visit 0). If there are tumors in both the kidney and the ureter, at least 1 biopsy should be taken from each location. 
  • Urine wash cytology sampled from the UUT documenting the absence of HG urothelial cancer.
  • Patients must have adequate organ and bone marrow function as determined by routine laboratory tests. 
  • Patient has no active urinary tract infection (UTI) as confirmed by urine culture or urinalysis

Exclusion Criteria:

  • Patient intends to be treated with systemic chemotherapy during the duration of the trial.
  • Patient with urinary obstruction. 
  • Inability to deliver the IP to the UUT.
  • Patient has any other medical or mental condition(s) that make(s) their participation in the trial unadvisable in the opinion of the treating investigator. 
  • Patient has a contraindication to mitomycin treatment, or known sensitivity to mitomycin.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Raymond Pak, M.D., M.B.A.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20477444

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