Not recruiting

Study on UGN-103 (Mitomycin) for Treating Low Grade Nonmuscle Invasive Bladder Cancer in Patients at Intermediate Risk of Recurrence

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of bladder cancer known as Nonmuscle Invasive Bladder Cancer (NMIBC). This form of cancer affects the bladder but does not invade the muscle layer. The study is specifically looking at patients with low-grade NMIBC who are at an intermediate risk of the cancer coming back. The treatment being tested is called UGN-103, which is a new formulation of a drug known as Mitomycin. This treatment is administered directly into the bladder in the form of a solution.

The purpose of the study is to evaluate how effective and safe UGN-103 is in treating this type of bladder cancer. Participants in the study will receive the treatment and will be monitored over a period of time to see how well the cancer responds. The study will involve regular check-ups, including procedures like cystoscopy, which is a way to look inside the bladder, and urine tests to check for cancer cells. The study will also track any side effects or reactions to the treatment to ensure it is safe for patients.

Throughout the study, the main goal is to see if the treatment can successfully remove the cancer and prevent it from returning. Participants will be followed for several months to observe the long-term effects of the treatment. This research aims to provide new insights into treating Nonmuscle Invasive Bladder Cancer and potentially offer a new option for patients with this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will be required to provide written informed consent. This consent confirms understanding and agreement to comply with the study requirements.
The patient must be at least 18 years old and have a confirmed diagnosis of low-grade nonmuscle invasive bladder cancer (LG NMIBC) through a biopsy.
Step 2
Screening and eligibility confirmation
The patient will undergo a screening process to confirm eligibility. This includes verifying a history of at least one prior episode of nonmuscle invasive bladder cancer and ensuring the disease is of intermediate risk.
Laboratory tests will be conducted to ensure adequate organ and bone marrow function. These tests include checking white blood cell count, platelet count, and kidney function, among others.
Step 3
Treatment administration
The treatment involves the administration of UGN-103, a formulation of Mitomycin, delivered directly into the bladder (intravesical use).
The medication is provided as a powder that is mixed into a solution for administration. The specific dosage and frequency will be determined by the study protocol.
Step 4
Monitoring and follow-up
The patient will be monitored regularly to assess the treatment's effectiveness and safety. This includes cystoscopy, urine tests, and possibly biopsies to evaluate the response to treatment.
The primary goal is to determine the complete response rate (CRR) at the three-month visit after the first treatment.
Step 5
Evaluation of treatment outcomes
Secondary evaluations will include the duration of response and monitoring for any adverse effects. This involves regular clinical assessments and laboratory tests.
Exploratory assessments may include changes in quality of life scores and analysis of biomarkers in tumor tissue.

Who can join the trial?

9 criteria

Provide written informed consent, which means you agree to follow the study's rules and understand what the study involves.
You must be 18 years of age or older.
You must have a type of bladder cancer called **Nonmuscle Invasive Bladder Cancer (NMIBC)**, confirmed by a specific type of biopsy within 8 weeks before the study starts. This biopsy checks the tumor's characteristics, but the tumor should not be removed during this process.
You must have had at least one previous episode of NMIBC before the current one being studied.
You should have **intermediate risk disease**, which means you have one or two of the following: multiple tumors, a single tumor larger than 3 cm, or a recurrence of NMIBC within one year of the current diagnosis. If you have all three, you are considered high risk and cannot participate.
You must have a negative result for **high-grade disease** in a test called voiding cytology within 8 weeks before the study.
Your organs and bone marrow must be functioning well, as shown by routine blood tests. These tests check things like white blood cells, platelets, and kidney function.
You should have a life expectancy that covers the duration of the trial.
Both male and female participants must use effective birth control methods during the study and for 6 months after treatment if they or their partners can have children. This includes methods like implants, injections, certain birth control pills, hormonal intrauterine devices, condoms with spermicide, or complete sexual abstinence. Periodic abstinence is not acceptable.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
Responsive
North Estonia Medical Centre Foundation
Tallin, Estonia
Responsive
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Plovdiv, Bulgaria

Trial locations

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Investigated drugs

UGN-103 is a new formulation of a medication called UGN-102. It is being studied for its ability to treat patients with a type of bladder cancer known as low-grade nonmuscle invasive bladder cancer. This medication is designed to help remove or reduce tumors in patients who are at an intermediate risk of the cancer coming back.

Poloxamer 407

What is already known about the treatment

UGN-103 – UGN-103 is administered directly into the bladder as a liquid formulation, specifically designed for treating low-grade nonmuscle invasive bladder cancer. It is currently being evaluated in clinical trials to determine its effectiveness and safety for patients at intermediate risk of cancer recurrence. The main therapeutic indication for UGN-103 is to treat bladder cancer by ablating tumors. At the molecular level, it works by delivering active ingredients directly to the bladder lining, where it targets and destroys cancer cells. UGN-103 is classified pharmacologically as a local chemotherapeutic agent.

Investigated diseases

Nonmuscle Invasive Bladder Cancer – This type of bladder cancer is characterized by the presence of cancerous cells in the bladder lining that have not spread into the muscle layer. It often presents with symptoms such as blood in the urine, frequent urination, or pain during urination. The disease progresses as the cancer cells grow and may form tumors on the bladder wall. Over time, if untreated, these tumors can become larger and potentially invade deeper layers of the bladder or spread to other parts of the body. The progression is typically monitored through regular cystoscopy and urine tests to detect any changes in the bladder lining.