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New treatment option for Urinary Bladder Cancer
Official title SeqUential GeMcitabine and MITomycin Treatment for Favorable High-Risk Upper Urinary Tract Urothelial Carcinoma
ClinicalTrials.gov ID: NCT06822010
What this study is testing
What is Sequential Gemcitabine and Jelmyto Treatment (Gem/Jel)?
Sequential Gemcitabine and Jelmyto Treatment (Gem/Jel) is an investigational medicine, given as an once-weekly treatment applied to the skin, being studied as a potential treatment for urinary bladder cancer.
Also referred to as Gemcitabine (endoluminal administration), Jelmyto (gel-based mitomycin, endoluminal administration).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- people must meet all of the following applicable 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.
You likely can't join if
- Invasive upper tract urothelial carcinoma (suspected cT2-4 on imaging) or lymphadenopathy (cN1-3) Bilateral disease Patient is actively being treated...
- 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...
See the full eligibility criteria
- people must meet all of the following applicable 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...
- 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 \ 40). 6\. Patients with life expectancy...
- Invasive upper tract urothelial carcinoma (suspected cT2-4 on imaging) or lymphadenopathy (cN1-3) Bilateral disease Patient is actively being treated or intends to be treated with systemic chemotherapy during the...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- New Brunswick, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Brunswick, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.