Study on the Safety and Effectiveness of Padeliporfin Therapy for Patients with Low-Grade Upper Tract Urothelial Cancer

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What is this study about?

This clinical trial is focused on studying a type of cancer called Low-Grade Upper Tract Urothelial Cancer (UTUC). This cancer affects the lining of the urinary system, specifically in areas like the kidney and ureter. The study is testing a treatment called TOOKAD (padeliporfin), which is a special therapy known as Vascular Targeted Photodynamic Therapy (VTP). This treatment involves using a drug that is activated by light to target and treat the cancer cells.

The purpose of the study is to evaluate how safe and effective TOOKAD is in treating this type of cancer. Participants in the study will receive the treatment through an intravenous infusion, which means the drug is given directly into a vein. The drug is then activated by a laser light delivery system, which helps to target the cancer cells more precisely. The study will monitor the participants over a period of time to see how well the treatment works and to check for any side effects.

Throughout the study, researchers will look for the absence of cancer in the treated areas, such as the kidney and ureter, using methods like endoscopy, which is a procedure that allows doctors to look inside the body. The study will also assess the overall health of the kidney and whether the treatment helps in preserving kidney function. Safety follow-ups will be conducted to record any adverse events experienced by the participants. The study aims to provide valuable information on the effectiveness and safety of TOOKAD in treating Low-Grade Upper Tract Urothelial Cancer.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, understanding of the study, and medical condition.

A biopsy confirms the presence of low-grade upper tract urothelial cancer (UTUC) in specific areas of the kidney.

2 treatment preparation

Preparation involves understanding the treatment process and potential outcomes.

The treatment uses TOOKAD (padeliporfin), a medication administered through an intravenous infusion.

3 treatment administration

The medication TOOKAD (padeliporfin) is given as a solution for injection.

The treatment is known as vascular targeted photodynamic therapy (VTP), which targets the cancerous areas.

4 post-treatment evaluation

After treatment, an endoscopic evaluation checks for the absence of UTUC tumors.

Success is defined by no visible tumors, negative biopsy results, and negative urinary cytology.

5 follow-up and monitoring

Regular follow-ups assess the duration of response and overall kidney function.

Safety monitoring includes recording any adverse events experienced during the study.

Who Can Join the Study?

Male and female patients who are 18 years or older.
Must be able to understand and provide written consent, and agree to follow all tests and procedures in the study.
Have a new or returning low-grade, non-invasive UTUC disease. UTUC stands for Upper Tract Urothelial Cancer, which affects the urinary system.
The disease must be confirmed by a biopsy, which is a small sample of tissue taken for testing. A central pathology expert must agree with the diagnosis for eligibility.
Can have up to 2 confirmed sites of low-grade cancer, with the largest tumor being between 5 mm and 15 mm in size, located in the calyces, renal pelvis, or ureter of the same kidney. There should be no high-grade cells found in urine tests. If the ureter is involved, it should be in one area and not more than 20 mm in length.
Must have a Karnofsky Performance Status of 50% or higher. This is a scale that measures the ability to perform daily activities, with higher percentages indicating better function.
Must have adequate organ function at the start of the study, defined as:
- ANC (Absolute Neutrophil Count) of 1,000 or more per microliter. Neutrophils are a type of white blood cell important for fighting infections.
- Platelets of 75,000 or more per microliter. Platelets help with blood clotting.
- Hemoglobin (Hb) of 9 grams per deciliter or more. Hemoglobin is a protein in red blood cells that carries oxygen.
- INR (International Normalized Ratio) of 2 or less. This is a measure of blood clotting.
- Estimated glomerular filtration rate (eGFR) of 30 ml/min or more, using the CKD-EPI Method. This measures kidney function.
- Total serum bilirubin less than 3 mg/dL. Bilirubin is a substance made during the breakdown of red blood cells.
- AST/ALT levels that are 5 times or less the upper limit of normal. These are liver enzymes, and their levels indicate liver health.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Technische Universitaet Dresden	Dresden	Germany

Other Sites

Site Name	City	Country
Hospital Edouard Herriot	Lyon	France
Centre Hospitalier Universitaire Rouen	Rouen	France
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Iwaczery Pqyojdpyrolijrh Crgoox Caiphu	Marseille	France
Avshars Ocpfxubgstx Uaxczmfemcphn Cudhltzgzuuj Dquiq Suspik E Dhwah Suytyyw Dn Tzuhwc	Turin	Italy
Ougggajhgvqvzn Labu Gboz	Linz	Austria
Hhiefled Vrjp duwyhiyn	Barcelona	Spain
Hrfkikbv Uodfiovejzybo dm A Cmmarx	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	22.03.2021
France	Recruiting	22.03.2021
Germany	Recruiting	22.03.2021
Italy	Not recruiting	22.03.2021
Spain	Recruiting	22.03.2021

Trial locations

Investigated drugs:

Padeliporfin

TOOKAD (padeliporfin) is a medication used in a therapy called Vascular Targeted Photodynamic Therapy (VTP). This treatment is designed to target and destroy cancer cells in specific areas of the body. In this clinical trial, TOOKAD is being used to treat low-grade upper tract urothelial cancer, which affects parts of the urinary system such as the calyces, renal pelvis, and ureter. The therapy works by activating the medication with light, which then helps to destroy the cancer cells while minimizing damage to surrounding healthy tissue.

Low Grade Upper Tract Urothelial Cancer – This is a type of cancer that occurs in the lining of the upper urinary tract, which includes the renal pelvis and ureter. It is characterized by the presence of abnormal cells that grow slowly and are less likely to spread compared to high-grade cancers. The disease progresses as these abnormal cells form tumors, which can obstruct the flow of urine and cause symptoms such as blood in the urine or pain. Over time, the tumors may grow larger and affect kidney function. The progression of the disease can vary, with some tumors remaining stable for long periods while others may grow or recur after treatment.

Trial ID:

2024-512322-28-00

Protocol code:

CLIN2001UCM301

NCT ID:

NCT04620239

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Safety and Effectiveness of Padeliporfin Therapy for Patients with Low-Grade Upper Tract Urothelial Cancer

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