Actively Recruiting
SeqUential GeMcitabine and MITomycin Treatment for Favorable High-Risk Upper Urinary Tract Urothelial Carcinoma
Led by Rutgers, The State University of New Jersey · Updated on 2026-05-06
28
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- Signed informed consent and willing to comply with the study requirements
- At least 18 years of age
- Naive or recurrent patients with high-grade Ta +/- CIS, non-invasive UTUC in upper tract confirmed by biopsy
- Underwent ureteroscopy with biopsy
- Non-invasive papillary carcinoma lesions must have no more than 15 mm residual papillary disease after ablation
- Favorable high-grade UTUC as per American Urological Association risk stratification (allowing multifocality, obstruction, ureteral or bladder involvement)
- Bladder involvement with NMIBC treated prior to or during treatment
- ECOG performance status less than 3 (Karnofsky greater than 40)
- Life expectancy greater than 24 months at screening
- No active urinary tract infection confirmed by urine culture or urinalysis
- Female patients of childbearing potential must have negative pregnancy test and agree to use two effective contraception methods until 6 months post treatment
- Sexually active male patients must use condom during intercourse for at least 48 hours post each instillation
- Male patients with female partners of childbearing potential must use two effective contraception methods until 6 months post treatment
- No medical condition making participation unadvisable per investigator
You will not qualify if you...
- Invasive upper tract urothelial carcinoma (suspected cT2-4) or lymphadenopathy (cN1-3)
- Bilateral disease
- Currently receiving or planning systemic chemotherapy during the trial
- Other malignancy diagnosed within 2 years except low-risk cancers like basal or squamous cell skin cancers, noninvasive cervix cancer, prostate or renal cancer under surveillance
- Administration not feasible via nephrostomy tube
- Unable to deliver investigational drug to pyelocalyceal system
- Medical or mental condition making participation unadvisable per treating urologist
- Contraindication or known sensitivity to mitomycin C
- Intractable bleeding disorder
- Currently receiving other investigational agents or participated in investigational product trial within 30 days prior to visit 1
- Pregnant, planning pregnancy, breastfeeding, or childbearing potential not using reliable contraception
AI-Screening
AI-Powered Screening
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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
CONTACT
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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