Gemcitabine + Jelmyto for Bladder Cancer

Overseen By Vignesh Packiam, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Rutgers, The State University of New Jersey

Must not be taking: Systemic chemotherapy, Investigational agents

Disqualifiers: Invasive UTUC, Bilateral disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 6-12 weeks

28 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for upper tract urothelial carcinoma (UTUC), a type of bladder cancer. The treatment uses two drugs, gemcitabine and Jelmyto (a formulation of mitomycin), to determine if they can effectively treat the cancer while preserving kidney function. Participants will receive the drugs directly into the kidney through a tube for several weeks. Individuals with non-invasive UTUC that cannot be surgically removed and who have managed the condition for some time might be suitable candidates. The trial aims to determine if this approach can avoid kidney removal and improve outcomes. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both gemcitabine and Jelmyto (a gel form of mitomycin) are generally safe. Gemcitabine is usually well-tolerated for bladder cancer treatment, with few serious side effects. Studies have found Jelmyto effective and safe for treating cancers in the upper urinary tract, and the FDA has already approved it for urothelial cancer.

Some patients might experience mild side effects, such as irritation at the application site. Clinical settings closely monitor the combined use of these two drugs to ensure safety. Overall, past research supports the safety of using these treatments together, although individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Gemcitabine + Jelmyto for bladder cancer because it offers a unique delivery method that sets it apart from traditional treatments like surgery or systemic chemotherapy. Unlike these options, this combination is directly administered into the affected area through a nephrostomy tube, targeting the tumor more precisely. This localized approach not only aims to maximize the treatment's impact on the tumor but also helps preserve kidney function, potentially leading to better long-term outcomes like recurrence-free survival.

What evidence suggests that this treatment might be an effective treatment for bladder cancer?

This trial will evaluate the combination of gemcitabine and Jelmyto for treating bladder cancer. Studies have shown that using gemcitabine with Jelmyto can be effective. Research indicates that gemcitabine is both safe and effective for this purpose. Jelmyto, a gel form of the drug mitomycin, has demonstrated long-term success in patients with upper tract urothelial carcinoma, a type of bladder cancer. In one study, 68% of patients who initially responded to Jelmyto did not experience cancer recurrence after three years. This trial aims to improve results by combining these two drugs to attack cancer cells while protecting kidney function. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

Patients with life expectancy greater than 24 months at time of screening

Patients must not have any other medical condition(s) that make(s) their participation in the study unadvisable in the opinion of the investigator

Patient has no active urinary tract infection (UTI) as confirmed by urine culture or urinalysis

Exclusion Criteria

Patient has contraindication to mitomycin C (MMC) treatment, or known sensitivity to MMC

Patient is currently receiving any other investigational agents or has participated in a research protocol involving administration of an investigational product within the past 30 days prior to Visit 1

I have invasive upper tract urothelial carcinoma or enlarged lymph nodes seen on scans.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants 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.

6-12 weeks

6-12 visits (in-person)

Follow-up

Participants are monitored for safety, recurrence-free survival, and patient-reported outcomes over time. Regular follow-up evaluations are conducted to assess long-term outcomes such as recurrence-free survival and kidney preservation.

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Gemcitabine
• Jelmyto (Mitomycin)

How Is the Trial Designed?

Group I: Sequential Gemcitabine and Jelmyto Treatment (Gem/Jel) Experimental Treatment 1 Intervention

Participants in this arm will receive six weekly doses of sequential gemcitabine and Jelmyto (mitomycin) directly administered into the affected kidney through a nephrostomy tube. Depending on the tumor's response, participants may receive an additional six weekly doses or transition to a standard of care maintenance regimen. The primary goal of this arm is to evaluate the complete response rate, safety, and long-term outcomes such as recurrence-free survival and kidney preservation. Interventions: Drug: Gemcitabine (endoluminal administration) Drug: Jelmyto (gel-based mitomycin, endoluminal administration)

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06822010

NCT06822010 | SeqUential GeMcitabine and MITomycin ...

The study focuses on sequential administration of two drugs, gemcitabine and Jelmyto (a gel-based form of mitomycin), to potentially preserve kidney function ...

2.

auajournals.org

auajournals.org/doi/10.1097/JU.0000000000004331

Long-Term Outcomes of Primary Chemoablation of Low- ...

We evaluate long-term outcomes of primary chemoablation using a mitomycin reverse thermal gel (UGN-101) in patients with low-grade upper tract ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10560344/

Adjuvant intraluminal therapies for upper tract urothelial ... - PMC

Gemcitabine intracavitary instillation has been shown to be a safe and effective treatment for urothelial bladder cancer (3). However, its significance as a ...

4.

investors.urogen.com

investors.urogen.com/news-releases/news-release-details/new-real-world-durability-response-data-jelmyto-reports-68/

New Real-World Durability of Response Data for JELMYTO ...

68% of patients with LG-UTUC who initially responded to JELMYTO had no evidence of disease recurrence at 3 years, as evaluated via endoscopy.

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1078143920303744

A polymeric paste-drug formulation for local treatment of ...

Moreover, a recent trial reports that adjuvant gemcitabine containing chemotherapy improves disease free survival, when administered to patients with pT2-T4 ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12126943/

Single bladder instillation of gemcitabine versus mitomycin C ...

Randomized clinical trials (RCTs) have provided robust evidence supporting the efficacy of a single postoperative intravesical chemotherapy instillation in ...

7.

urotoday.com

urotoday.com/video-lectures/journal-clubs/video/1815-journal-club-the-efficacy-and-safety-of-mitogel-on-ablation-of-upper-urinary-tract-urothelial-carcinoma-olympus.html

Journal Club: The Efficacy and Safety of MitoGel™ (UGN-101 ...

Based on these results, the FDA approved mitomycin gel for urothelial cancer on April 15th, 2020 under the trade name of Jelmyto™. So several ...

8.

targetedonc.com

targetedonc.com/view/sequential-mitomycin-with-bcg-is-shown-to-be-safe-in-high-risk-nmibc

Sequential Mitomycin With BCG Is Shown to Be Safe in ...

Results from the phase 4 MITO-BCG study show safety of sequential mitomycin with BCG for the treatment of high-risk muscle invasive bladder cancer.