Stereotactic Body Radiation Therapy and Aflibercept in Treating Patients With Uveal Melanoma

Uveal Melanoma Clinical Trial

Official title: Phase II Randomized Trial of Stereotactic Radiotherapy (SRT) Followed by Intravitreal Aflibercept Injection for Patients With Ocular Melanoma

Status Completed

Clinical Trial Summary

This phase II trial studies how well stereotactic body radiation therapy and aflibercept work in treating patients with uveal melanoma. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Aflibercept may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving stereotactic body radiation therapy followed by aflibercept may work better in treating patients with uveal melanoma.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To assess the percentage of patients able to successfully complete their prescribed treatment of radiation and intravitreal ziv-aflibercept (aflibercept) injection (IAI) with an acceptable level of toxicity.

SECONDARY OBJECTIVES:

I. To assess for reduction in the incidence of 2-year rates of radiation maculopathy, radiation papillopathy, functional vision preservation, radiation glaucoma, and to assess 2-year local control and progression-free survival. ;

Related Conditions & MeSH terms

• Melanoma
• Uveal Melanoma

• NCT number: NCT03712904
• Study type: Interventional
• Source: Thomas Jefferson University
• Status: Completed
• Phase: Phase 2
• Start date: August 9, 2019
• Completion date: December 23, 2022