NCT06822010

SeqUential GeMcitabine and MITomycin Treatment for Favorable High-Risk Upper Urinary Tract Urothelial Carcinoma

A Phase II Trial of SeqUential GeMcitabine and MITomycin Treatment for Favorable High-Risk Upper Urinary Tract Urothelial Carcinoma (SUMMIT)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This Phase II clinical trial, titled "A Phase II Trial of Sequential Gemcitabine and Mitomycin Treatment for Favorable High-Risk Upper Urinary Tract Urothelial Carcinoma (SUMMIT)," aims to evaluate the safety and effectiveness of a combination chemotherapy treatment for patients with favorable papillary high-grade upper tract urothelial carcinoma (UTUC). The study focuses on sequential administration of two drugs, gemcitabine and Jelmyto (a gel-based form of mitomycin), to potentially preserve kidney function and avoid nephroureterectomy (kidney removal), which is the current standard of care for participants with non-endoscopically resectable tumors.

Detailed description

Participants enrolled in the study will receive six weekly doses of gemcitabine and Jelmyto delivered directly into the affected kidney through a nephrostomy tube. Based on the tumor's response, patients may receive an additional six doses or transition to a standard maintenance regimen. The primary goal is to assess the complete response rate of this treatment and determine its effectiveness in preserving kidney function while managing cancer recurrence. Secondary objectives include evaluating safety, recurrence-free survival at 12 and 24 months, and patient-reported outcomes over time. The study is expected to last approximately 3 years, with participants undergoing regular follow-up evaluations. If the treatment is ineffective, standard procedures such as nephroureterectomy may still be performed.

Conditions

• Urinary Bladder Cancer
• Upper Tract Urothelial Cancer
• Urothelial Cancer

Interventions

Type	Name	Description
DRUG	Sequential Gemcitabine and Jelmyto Treatment (Gem/Jel)	Drug: Gemcitabine (endoluminal administration) Drug: Jelmyto (gel-based mitomycin, endoluminal administration)

Timeline

• Start date: 2026-06-01
• Primary completion: 2028-04-01
• Completion: 2029-04-01
• First posted: 2025-02-12
• Last updated: 2025-11-14

Regulatory

• FDA-regulated drug study