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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Undergo radiation
Given IV
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Incidence of Adverse Events
Percent of patients who experience Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade ≥3 toxicity related to SRT and/or intravitreal Aflibercept.
Time frame: Up to approximately 6 months
Radiation Maculopathy Rate Defined as Ophthalmoscopic Detection of Macular Edema Perivascular Sheathing
Will be estimated separately in each arm with the corresponding exact binomial 90% confidence interval.
Time frame: At 2 years
Radiation Papillopathy Rate Defined as Ophthalmoscopic Detection of Peripapillary Encircling Nerve Fiber Layer Infarction
Will be estimated separately in each arm with the corresponding exact binomial 90% confidence interval.
Time frame: At 2 years
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