A Phase II Trial of SeqUential GeMcitabine and MITomycin Treatment for Favorable High-Risk Upper Urinary Tract Urothelial Carcinoma (SUMMIT)
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.
• Subjects must meet all of the following applicable inclusion criteria to participate in the study:
‣ Patient has signed Informed Consent Form and is willing and able to comply with all requirements of the protocol.
⁃ Patient is at least 18 years of age.
⁃ 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 with ≤ 15 mm residual papillary disease in total.
• 4\. Favorable high-grade upper tract urothelial carcinoma (UTUC) as per American Urological Association (AUA) risk stratification below (except that multifocality, obstruction, ureteral involvement, bladder involvement will be allowed).
⁃ If the bladder is involved with NMIBC it should be treated prior to or during Gem/Jel treatments.
‣ 5\. Patients with ECOG (Eastern Cooperative Oncology Group) performance status \<3 (with Karnofsky \>40).
‣ 6\. Patients with life expectancy greater than 24 months at time of screening. 7. Patient has no active urinary tract infection (UTI) as confirmed by urine culture or urinalysis\*.
‣ 8\. Female Patients of childbearing potential\*\*, must have a negative serum pregnancy test at screening and must agree to use two acceptable \& effective methods of contraception\*\*\*, until 6 months post treatment 9. All sexually active male patients must agree to use a condom during intercourse, for at least 48 hours post each instillation.
‣ 10\. Male patients who have a partner that is a female of childbearing potential must agree to use two acceptable \& effective methods of contraception until 6 months post treatment.
‣ 11\. Patients must not have any other medical condition(s) that make(s) their participation in the study unadvisable in the opinion of the investigator.