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.
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.
At least 12 months since the last menses, or
Without uterus and/or both ovaries, or
Has been surgically sterile for at least 6 months prior to trial drug administration.
Acceptable methods of birth control which are considered to have a low failure rate (i.e., less than 1% per year) when used consistently and correctly, such as implants, injectable, combined (estrogen/progesterone) oral contraceptives, intrauterine devices (IUDs-only hormonal), condoms with spermicide, sexual abstinence or vasectomized partner.
Single group
Sequential Gemcitabine and Jelmyto Treatment (Gem/Jel)
DrugDrug: Gemcitabine (endoluminal administration) Drug: Jelmyto (gel-based mitomycin, endoluminal administration)
Complete Response (CR) Rate
The proportion of participants who achieve a complete response, defined as the absence of detectable high-grade disease via ureteroscopy, imaging (CTU/MRU), and urine cytology following the completion of the initial Gem/Jel treatment regimen. A complete response indicates no visible tumor during endoscopic evaluation and no evidence of cancer cells in collected samples
Safety and Incidence of Adverse Events
Frequency and severity of adverse events associated with the sequential Gem/Jel treatment, including drug-related toxicities and complications related to the nephrostomy tube, evaluated using Common Terminology Criteria for Adverse Events (CTCAE) criteria CTCAE) guidelines, which categorize the severity of side effects on a scale from mild (grade 1) to severe (grade 5).
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