This phase II trial studies how well stereotactic body radiation therapy and aflibercept work in treating patients with uveal melanoma. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Aflibercept is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving stereotactic body radiation therapy followed by aflibercept may work better in treating patients with uveal melanoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03712904.
PRIMARY OBJECTIVE:
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 OBJECTIVE:
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.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients undergo stereotactic body radiation therapy over 5 fractions every other week day during days 1-10. Patients then receive ziv-aflibercept via intravitreal injection (IVI) at 4 months after radiation therapy and then every 2 months for up to 2 years in the absence of disease progression or unacceptable toxicity.
ARM B: Patients undergo stereotactic body radiation therapy as in arm A. Patients then receive ziv-aflibercept IVI at 4 months after radiation therapy and then every 4 months for up to 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment patients are followed up at 2 months.
Lead OrganizationThomas Jefferson University Hospital
Principal InvestigatorWenyin Shi
