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Melphalan Chemoreduction for Ocular Melanoma
Sponsor: Hospital das Clínicas de Ribeirão Preto
Summary
The goal of this clinical trial is to investigate a new approach for treating large uveal melanomas, a type of eye cancer. The study aims to determine the effectiveness of using intra-arterial melphalan, a chemotherapy drug, to reduce tumor thickness, allowing for subsequent radiation therapy using a Ru-106 plaque. The main questions this trial seeks to answer are: * Can intra-arterial melphalan effectively reduce the thickness of large uveal melanomas? * Is the combination of intra-arterial melphalan and brachytherapy a safe and effective treatment option for these tumors? Participants enrolled in the trial have clinically diagnosed choroidal melanoma with tumor thickness equal to or greater than 8.00 mm. They will undergo a procedure where the chemotherapy drug is injected directly into the blood vessels that supply the tumor. After a few weeks, they will receive the radiation treatment using a small device placed on the eye. Throughout the trial, participants will have different tests to monitor the tumor and their vision, such as ultrasound scans, pictures of the inside of the eye, and a test called electroretinography (ERG) to check the function of the retina. These tests will be done at the start of the trial and at 1, 3, and 6 months later to track the progress of the treatment.
Official title: Melphalan Intra-arterial Chemotherapy for Choroidal Melanoma Chemoreduction - a Phase I Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2021-05-01
Completion Date
2025-12
Last Updated
2025-09-15
Healthy Volunteers
No
Conditions
Interventions
Melphalan Injection
7.5mg of melphalan injected via intra-arterial catheterization of the ophthalmic artery.
Plaque brachytherapy
Brachytherapy will be performed using a 24-mm notched plaque with Ruthenium-106 seeds.
Locations (1)
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP
Ribeirão Preto, São Paulo, Brazil