NCT05893654Enrolling by invitationPhase 1/2
Melphalan Chemoreduction for Ocular Melanoma
Melphalan Intra-arterial Chemotherapy for Choroidal Melanoma Chemoreduction - a Phase I Clinical Trial
Source: ClinicalTrials.gov · Last updated 15 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 18 May 2023
- Start date
- 1 May 2021
- Primary completion date
- Dec 2025
- Lead sponsor
- Hospital das Clínicas de Ribeirão Preto
- Diseases
- Melanoma
- NCT number
- NCT05893654
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 10
- From 1 May 2021 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Choroidal melanomas with a greatest basal diameter higher than 18mm
- Pregnancy, breastfeeding, or plans of getting pregnant in the next year
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP Coordinator of this site? Confirm its status | Ribeirão Preto | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.