Clinical trial · Interventional
Melphalan Chemoreduction for Ocular Melanoma
Melphalan Intra-arterial Chemotherapy for Choroidal Melanoma Chemoreduction - a Phase I Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uveal Melanoma | Uveal Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Melphalan Injection | Drug | Melphalan | ALIAS |
| Plaque brachytherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm
- description
- Participants will undergo intra-arterial catheterization of the ophthalmic artery, with administration of 7.5mg of melphalan. After 4±1 weeks, they will receive Ru-106 plaque brachytherapy, which will be performed using a 24-mm notched plaque. Due to tumor thickness and the previous IAC, the target dose to the tumor apex shall be as close as possible to 80 Gy, respecting the safety limits regarding the risk of excessive dosage to the tumor base and scleral melting.
- interventionNames
- Drug: Melphalan Injection
- Radiation: Plaque brachytherapy
Primary outcomes (1)
- measure
- Determination of treatment safety through electroretinography (ERG)
- timeFrame
- 6 months
- description
- Participants will undergo ERG exams at baseline, 1, 3, and 6 months after the first intervention. The researchers will assess the patterns of ERG waves to determine whether there are signs of retinal toxicity.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * Choroidal melanomas with a greatest basal diameter higher than 18mm * Any clinical condition that impairs fundus documentation or patient follow-up * Medical or psychological conditions that prevent comprehension and signature of the informed consent * Pregnancy, breastfeeding, or plans of getting pregnant in the next year * Past medical history of allergic reactions or hypersensitivity to melphalan
References
Publications (14)
- BACKGROUNDKrantz BA, Dave N, Komatsubara KM, Marr BP, Carvajal RD. Uveal melanoma: epidemiology, etiology, and treatment of primary disease. Clin Ophthalmol. 2017 Jan 31;11:279-289. doi: 10.2147/OPTH.S89591. eCollection 2017. PMID 28203054
- BACKGROUNDSingh M, Durairaj P, Yeung J. Uveal Melanoma: A Review of the Literature. Oncol Ther. 2018 Jun;6(1):87-104. doi: 10.1007/s40487-018-0056-8. Epub 2018 Feb 6. PMID 32700136
- BACKGROUNDAmerican Brachytherapy Society - Ophthalmic Oncology Task Force. Electronic address: paulfinger@eyecancer.com; ABS - OOTF Committee. The American Brachytherapy Society consensus guidelines for plaque brachytherapy of uveal melanoma and retinoblastoma. Brachytherapy. 2014 Jan-Feb;13(1):1-14. doi: 10.1016/j.brachy.2013.11.008. Epub 2013 Dec 24. PMID 24373763
- BACKGROUNDReichstein DA, Brock AL. Radiation therapy for uveal melanoma: a review of treatment methods available in 2021. Curr Opin Ophthalmol. 2021 May 1;32(3):183-190. doi: 10.1097/ICU.0000000000000761. PMID 33770014
- BACKGROUNDParker T, Rigney G, Kallos J, Stefko ST, Kano H, Niranjan A, Green AL, Aziz T, Rath P, Lunsford LD. Gamma knife radiosurgery for uveal melanomas and metastases: a systematic review and meta-analysis. Lancet Oncol. 2020 Nov;21(11):1526-1536. doi: 10.1016/S1470-2045(20)30459-9. PMID 33152286
- BACKGROUNDMarinkovic M, Pors LJ, van den Berg V, Peters FP, Schalenbourg A, Zografos L, Pica A, Hrbacek J, Van Duinen SG, Vu THK, Bleeker JC, Rasch CRN, Jager MJ, Luyten GPM, Horeweg N. Clinical Outcomes after International Referral of Uveal Melanoma Patients for Proton Therapy. Cancers (Basel). 2021 Dec 13;13(24):6241. doi: 10.3390/cancers13246241. PMID 34944862
- BACKGROUNDThariat J, Martel A, Matet A, Loria O, Kodjikian L, Nguyen AM, Rosier L, Herault J, Nahon-Esteve S, Mathis T. Non-Cancer Effects following Ionizing Irradiation Involving the Eye and Orbit. Cancers (Basel). 2022 Feb 25;14(5):1194. doi: 10.3390/cancers14051194.