Chemotherapy Before Radiation for Large Eye Melanoma
Tests chemotherapy delivered into eye blood vessels before radiation in adults with large uveal melanoma.
Plain-language title generated from the registry record
Registry title: Melphalan Chemoreduction for Ocular Melanoma
Key facts
- Where
- Ribeirão Preto, BrazilSee the site
- Phase
- Phase 1/2
Where in Brazil
- Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USPRibeirão Preto, BrazilNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hospital das Clínicas de Ribeirão Preto
- Trial code
- NCT05893654
- Record updated
- 15 September 2025
- Original description
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.Read full original descriptionShow less
Melphalan Intra-arterial Chemotherapy for Choroidal Melanoma Chemoreduction - a Phase I Clinical Trial
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.
Inclusion: Age equal to or higher than 18 years; Diagnosis of choroidal melanoma with a thickness equal to or higher than 8 mm on ultrasound evaluation; Comprehension and signature of the informed consent; Adequate pupil dilation and sufficient cooperation to carry out the complementary exams.
Exclusion: Any clinical condition that impairs fundus documentation or patient follow-up; Medical or psychological conditions that prevent comprehension and signature of the informed consent; Past medical history of allergic reactions or hypersensitivity to melphalan; Choroidal melanomas with a greatest basal diameter higher than 18mm; Pregnancy, breastfeeding, or plans of getting pregnant in the next year.