Actively Recruiting
A Phase II Trial of Sequential Gemcitabine and Mitomycin Treatment for Favorable High-Risk Upper Urinary Tract Urothelial Carcinoma (SUMMIT)
Led by Rutgers, The State University of New Jersey · Updated on 2026-05-06
28
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combination chemotherapy treatment for patients with favorable papillary high-grade upper tract urothelial carcinoma (UTUC). This Phase II trial aims to assess the safety and effectiveness of sequentially administering gemcitabine and Jelmyto (a gel-based form of mitomycin) to potentially preserve kidney function and avoid the standard treatment of kidney removal, known as nephroureterectomy. Participants will receive six weekly doses of gemcitabine and Jelmyto directly into the affected kidney through a nephrostomy tube. Depending on the tumor's response, patients may receive an additional six doses or begin a standard maintenance regimen. The study focuses on measuring the complete response rate to this treatment and its ability to manage cancer recurrence while preserving kidney health. During the study, participants will have regular follow-up evaluations lasting about three years. Researchers will monitor safety, recurrence-free survival at 12 and 24 months, and patient-reported outcomes. If the treatment is not effective, patients may still undergo the standard kidney removal procedure. The primary outcome is the complete response rate at the end of the initial treatment phase, with ongoing safety monitoring throughout the study period.
CONDITIONS
Brief Title
SeqUential GeMcitabine and MITomycin Treatment for Favorable High-Risk Upper Urinary Tract Urothelial Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has signed Informed Consent Form and agrees to follow the study protocol
- Patient is at least 18 years old
- Diagnosed with high-grade Ta +/- CIS, non-invasive upper tract urothelial carcinoma (UTUC) in the upper tract
- Histologic confirmation with biopsy and ureteroscopy with biopsy required
- Non-invasive papillary carcinoma lesions must be mostly removed with no more than 15 mm residual disease
- Favorable high-grade UTUC as defined by American Urological Association risk, with some exceptions allowed
- Bladder involvement with non-muscle invasive bladder cancer (NMIBC) must be treated before or during study treatment
- ECOG performance status less than 3 and Karnofsky score above 40
- Life expectancy over 24 months at screening
- No active urinary tract infection confirmed by urine tests
- Female patients of childbearing potential must have a negative pregnancy test and agree to use two effective contraception methods until 6 months after treatment
- Sexually active male patients must use condoms for at least 48 hours after each treatment
- Male patients with female partners of childbearing potential must use two effective contraception methods until 6 months after treatment
- No other medical conditions that would make participation unsafe as judged by the investigator
You will not qualify if you...
- Invasive upper tract urothelial carcinoma suspected on imaging or lymphadenopathy
- Bilateral disease
- Currently receiving or planning systemic chemotherapy during the trial
- Other malignancies diagnosed within 2 years except certain low-risk cancers like basal or squamous cell skin cancers, noninvasive cervical cancer, or cancers under active surveillance
- Inability to administer treatment via nephrostomy tube
- Inability to deliver the investigational drug to the kidney collecting system
- Medical or mental conditions that make participation unsafe as judged by the treating urologist
- Known sensitivity or contraindication to mitomycin C
- Intractable bleeding disorders such as coagulation factor deficiencies or Von Willebrand Disease
- Currently receiving other investigational treatments or participated in a trial with investigational product within 30 days prior to study start
- Pregnant, planning pregnancy, breastfeeding, or childbearing potential without reliable contraception
- Active urinary tract infection not resolved prior to treatment start as per clinical discretion and urine culture
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 to 12 weeks
Participants receive six weekly doses of gemcitabine and Jelmyto administered directly into the affected kidney through a nephrostomy tube. Based on tumor response, participants may receive an additional six weekly doses or transition to a standard maintenance regimen.
Weekly visits for up to 12 weeks
Duration - Up to 3 years
Participants undergo regular follow-up evaluations for up to 3 years to monitor safety, recurrence-free survival, kidney function, and patient-reported outcomes.
Regular follow-up visits over 3 years
Trial Site Locations
Total: 1 location
1
Rutgers Cancer Institute
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
Research Team
V
Vignesh Packiam, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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