Study on Sequential Gemcitabine and Mitomycin Treatment for High-Risk Upper Urinary Tract Cancer

Sponsor: Rutgers, The State University of New Jersey

Sponsor score: 40

ClinicalTrials ID:NCT06822010

Provider View

This clinical trial is testing a combination of two chemotherapy drugs, gemcitabine and Jelmyto, to see if they can effectively treat high-risk upper urinary tract cancer while preserving kidney function and avoiding surgery.

Patient Parameters

Program Overview

This Phase II study, called SUMMIT, is exploring a new treatment approach for patients with high-risk upper urinary tract urothelial carcinoma (UTUC). The trial aims to determine if using two chemotherapy drugs, gemcitabine and Jelmyto (a gel form of mitomycin), can safely and effectively treat this type of cancer. The goal is to preserve kidney function and avoid the need for kidney removal surgery, which is the current standard treatment for tumors that cannot be removed endoscopically.

Description

Participants in this study will receive six weekly treatments of gemcitabine and Jelmyto, which are delivered directly into the affected kidney through a tube. Depending on how the tumor responds, patients may receive an additional six treatments or switch to a standard maintenance plan. The main goal is to see how well this treatment works in eliminating cancer and preserving kidney function. The study will also look at safety, how long patients remain cancer-free, and their quality of life over time. The study will last about three years, with regular follow-up visits. If the treatment doesn't work, standard procedures like kidney removal may still be necessary.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have signed an informed consent form and be willing to follow study requirements.
  • Have high-grade non-invasive upper tract urothelial carcinoma (UTUC) confirmed by biopsy.
  • Tumors must be treated to leave no more than 15 mm of papillary disease.
  • Cancer must be classified as favorable high-grade UTUC according to specific criteria.
  • Must have a performance status score of less than 3.
  • Must have a life expectancy of more than 24 months.
  • Must not have an active urinary tract infection.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and for six months after treatment.
  • Men must agree to use a condom during intercourse for at least 48 hours after each treatment and use effective contraception if their partner is of childbearing potential.
  • Must not have any other medical conditions that would make participation inadvisable.

Exclusion Criteria

  • Have invasive upper tract urothelial carcinoma or lymph node involvement.
  • Have cancer on both sides of the urinary tract.
  • Are receiving or plan to receive systemic chemotherapy during the trial.
  • Have had another cancer diagnosed within two years, except for certain low-risk cancers.
  • Cannot receive treatment through a nephrostomy tube.
  • Have a medical condition that makes participation inadvisable.
  • Have a known allergy to mitomycin C or a bleeding disorder.
  • Are currently in another clinical trial or have taken investigational drugs within the last 30 days.
  • Are pregnant, planning to become pregnant, or breastfeeding, and not using reliable contraception.

Locations

FACILITYZIPCITYSTATE
Rutgers Cancer Institute08901New BrunswickNew Jersey

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