Study of UGN-104 (mitomycin) treatment for patients with low-grade upper tract urothelial cancer

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What is this study about?

This clinical trial focuses on patients with Low-grade Upper Tract Urothelial Cancer, a type of cancer that develops in the lining of the kidney’s collecting system. The study will test a new medicine called UGN-104, which contains the active substance mitomycin. This treatment comes in the form of a powder that is mixed into a solution before use.

The purpose of this research is to evaluate how effective UGN-104 is at removing tumors in patients with this type of cancer. The medication will be given directly into the upper urinary tract through a procedure called intravesical administration. Each patient will receive six treatments of the medicine over a treatment period that can last up to 12 months.

After completing the treatment, patients will have a check-up approximately 5 weeks after their final dose to determine if the treatment was successful in eliminating the cancer. The study will continue to monitor patients to see how long the treatment effects last and to check for any side effects. Throughout the study, doctors will perform various tests to ensure patient safety, including blood tests and imaging of the urinary tract.

1 Initial assessment

Your medical team will perform a detailed evaluation to confirm low-grade upper tract urothelial cancer diagnosis

Laboratory tests will be conducted to check organ function and blood counts

A visual examination of tumors in the upper urinary tract will be performed

2 Treatment preparation

The medical team will ensure there is no active urinary tract infection before starting treatment

If infection is present, antibiotics will be prescribed and treatment will be delayed until resolved

3 Treatment administration

UGN-104 medication will be administered directly into the upper urinary tract

You will receive six treatments in total

The medication is a special powder form that is prepared for administration

4 Post-treatment evaluation

5 weeks (plus/minus 1 week) after the sixth treatment, a detailed examination will be performed

This examination includes: urine tests, visual examination of the urinary tract, and if needed, a tissue sample

The medical team will assess if the treatment has been effective in removing the cancer

5 Follow-up period

Regular check-ups will be scheduled to monitor your condition

Safety assessments will include blood tests, urine analysis, physical examinations, and vital signs monitoring

You will be asked to complete questionnaires about your health and treatment experience

6 Safety considerations

Male patients must use appropriate contraception for 48 hours after each treatment

All patients must use two forms of effective contraception during the study and for 6 months afterward

Regular monitoring of side effects and any health changes will continue throughout the study

Who Can Join the Study?

  • Must provide written informed consent and agree to follow study requirements
  • Must be 18 years or older
  • Must have low-grade, non-invasive upper tract urothelial cancer in the kidney collection system with:
    • At least 1 measurable tumor no larger than 15 millimeters
    • At least 1 tumor must be at least 5 millimeters in size after biopsy
    • Biopsy confirming low-grade cancer
    • Urine test showing no signs of high-grade cancer
  • Must have good physical function status (ECOG score less than 3, which means able to care for self but unable to work)
  • Must have life expectancy of more than 24 months
  • Must have adequate organ function shown by blood tests including:
    • Normal white blood cell counts
    • Normal platelet levels
    • Adequate hemoglobin levels
    • Normal liver function tests
    • Adequate kidney function
  • Must not have active urinary tract infection
  • Must agree to use effective birth control:
    • Both men and women must use two forms of birth control during study
    • Men must use condoms for 48 hours after each treatment
    • Birth control must continue for 6 months after treatment ends

Who Cannot Join the Study?

  • Age under 18 years old
  • Patients with high-grade urothelial cancer (more aggressive form of cancer in the urinary tract)
  • Previous treatment with chemotherapy or immunotherapy within the last 6 months
  • Presence of metastatic disease (cancer that has spread to other parts of the body)
  • Severe kidney dysfunction
  • Active urinary tract infection
  • Pregnant or breastfeeding women
  • History of allergic reactions to similar medications
  • Participation in another clinical trial within the last 30 days
  • Significant heart, liver, or other medical conditions that could interfere with study participation
  • Unable to follow study procedures or attend required visits
  • Current substance abuse or mental health conditions that could affect compliance

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Institutul Regional De Oncologie Iasi Iasi Romania
Multidisciplinary Hospital For Active Treatment Haskovo AD Haskovo Bulgaria
Uniwersytecki Szpital Kliniczny W Opolu Opole Poland
In Vivo Sp. z o.o. Bydgoszcz Poland
Fundacio Puigvert Barcelona Spain
Uasnnqvboq Mipwxmeypffk Hrcqocxb Fyo Auafgx Tdoybjlum Aec Enuipjynx Mzhbgvqx N I Pakofxb Sofia Bulgaria
Uaemmeywrx Oo Dmuknzkn Debrecen Hungary
Hvqiszsk Uyqignukljhzg dk A Cczoed A Coruna Galicia Spain
Hqfropox Cyhsmne Sgd Cmaizw Madrid Spain
Cwcgfso Oyetcyceqap Cmzekg &irxjix Sznkku Emoh Shumen Bulgaria
Hzrsnzky Ulsoovbfroamh Dj Ln Pzsyoqbr Madrid Spain
Czjzcew Ovkzyakvi Zyirr Ljbcfwoynn Img Swk Jdhk Z Dkmix Lublin Poland
Dxpyf Hmblct Cimm Saihaf Bucharest Romania
Slorgot Klxwndfwx Mjspegfkydgw Spdtx Wrfjtkoknkjj I Acpawyddakgtr Z Wdegwjarfajooearphd Cqbwkob Oynxgocdz W Opfafyscd Olsztyn Poland
Pymte Szdbjcqk Cvrrmsla Uawizjvzma Hsbasmms Riga Latvia
Ujmxxrdihk Mlxpaegtqush Huibluka Fxh Apmgvf Tqppwclin Siddw Goxunh Egv Plovdiv Bulgaria
Skwzvzoc Cavudk Jhwtbyiy Dt Uoxdkjv Bmjgv Oradea Romania
Sltfbakd Cchrdi Jgdwdcoi Dv Unyrwji Pcqp Btowgaw Timisoara Romania
Sy Zbv Myuiqluiukwn Sjtsr Wunnmqpyxrnu w Pbwdwbvg ich Pepef Lzxldgf Bzldtoxjnstbf Poznan Poland
Msab Vdqlo Exuf Varna Bulgaria
Spmdbphj Ceprov Jhdzmkhx Du Uzyulki Bwffzi Brasov Romania
Uqbxpuvbymmik Sicofgf Kdsnmkqre Nh 2 Pzy W Slnbncxmqe Szczecin Poland
Prnskomwhklxztmk Wfoaesraboxvh Jylv Sgn z omev Katowice Poland
Rshug Akyptjjz kizoefvt ugrqiuqthlsdq stljiuxf Swk Riga Latvia
Lpikmsvg Rtunarung Swixqrhz Swt Liepaja Latvia
Hrjnijqf Uomvpqesazmyt Plskar Dwh Mdy Cadiz Spain
Hxsaspyc Gsjuaxc Uhhyzqejbeeid Mbdkbns Mruenjnd Murcia Spain
Dnmuxkoroa rihbusfih scmeidgx Swm Daugavpils Latvia
Swyvzbta Csvpvy Mannfnrpu Cjgdjgyiiog Cluj Napoca Romania
Scusdqdh Colkmb Dp Njndgxtxzp Ddg Casxk Dyvaag Bucharest Romania
Ssfsnva Manfzwu Sfezdlyaudloswv Iws Gpqeccxe Ncxfpljllbw W Kvthzyhp Cracow Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Recruiting
26.06.2025
Hungary Hungary
Recruiting
26.06.2025
Latvia Latvia
Recruiting
26.06.2025
Poland Poland
Recruiting
26.06.2025
Romania Romania
Recruiting
26.06.2025
Spain Spain
Recruiting
26.06.2025

Trial locations

Investigated Drugs:

UGN-104 is an investigational medication delivered directly to the upper urinary tract. It is a novel formulation of UGN-101, designed to treat low-grade upper tract urothelial cancer. This medication is applied locally to target cancer cells in the urinary system, specifically in the upper parts of the urinary tract. The medication is being studied as a potential treatment option that may help eliminate tumors in this specific area of the body.

Low-grade Upper Tract Urothelial Cancer – A rare form of cancer that develops in the lining of the upper urinary tract, specifically in the renal pelvis or ureter. This cancer begins in the urothelial cells (also called transitional cells) that line these structures. The term “low-grade” indicates that the cancer cells appear more similar to normal cells and tend to grow more slowly than high-grade cancers. The disease typically develops gradually, with cancer cells growing within the inner lining of the urinary tract. It can occur in one or multiple locations within the upper urinary system.

Trial ID:
2024-519343-15-00
Protocol code:
UT002
NCT ID:
NCT06774131
Trial Phase:
Therapeutic confirmatory (Phase III)

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