A Phase II Trial of SeqUential GeMcitabine and MITomycin Treatment for Favorable High-Risk Upper Urinary Tract Urothelial Carcinoma (SUMMIT)
Rutgers, The State University of New Jersey
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.
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…
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Subjects must meet all of the following applicable inclusion criteria to participate in the study: 1. Patient has signed Informed Consent Form and is willing and able to comply with all requirements of the protocol. 2. Patient is at least 18 years of age. 3. Naive or recurrent patients with High Grade Ta +/- CIS, non-invasive UTUC in the upper tract (pyelocalyceal system or ureter). * Histologic confirmation with biopsy is necessary. * All patients must undergo ureteroscopy with biopsy. * Non-Invasive Papillary Carcinoma (HGTa) lesions must be maximally ablated wi…
Interventions
- DrugSequential Gemcitabine and Jelmyto Treatment (Gem/Jel)
Drug: Gemcitabine (endoluminal administration) Drug: Jelmyto (gel-based mitomycin, endoluminal administration)
Location
- Rutgers Cancer InstituteNew Brunswick, New Jersey