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

Part of paid clinical trials in New Brunswick, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT06822010
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 6, 2026
Status verified
May 2026
Primary completion
Apr 1, 2028
Completion
Apr 1, 2029

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sequential Gemcitabine and Jelmyto Treatment (Gem/Jel)
    Participants in this arm will receive six weekly doses of sequential gemcitabine and Jelmyto (mitomycin) directly administered into the affected kidney through a nephrostomy tube. Depending on the tumor's response, participants may receive an additional six weekly doses or transition to a standard of care maintenance regimen. The primary goal of this arm is to evaluate the complete response rate, safety, and long-term outcomes such as recurrence-free survival and kidney preservation. Interventions: Drug: Gemcitabine (endoluminal administration) Drug: Jelmyto (gel-based mitomycin, endoluminal administration)

Primary Outcome Measure

Complete Response (CR) Rate [ Time Frame: At the end of the initial 6-week induction phase (up to 12 weeks if re-induction is necessary) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rutgers Cancer InstituteNew BrunswickNew Jersey08901
Vignesh Packiam, MD
[email protected]
732-235-2465

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