Phase II Randomized Trial of Stereotactic Radiotherapy (SRT) Followed by Intravitreal Aflibercept Injection for Patients With Ocular Melanoma
Overview
- Phase
- Phase 2
- Intervention
- Stereotactic Body Radiation Therapy
- Conditions
- Uveal Melanoma
- Sponsor
- Sidney Kimmel Cancer Center at Thomas Jefferson University
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Incidence of Adverse Events
- Status
- Terminated
- Last Updated
- 7 months ago
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Provide signed and dated informed consent form or have a Legally Authorized Representative (LAR) who can give consent
- •Willing to comply with all study procedures and be available for the duration of the study
- •Must be a candidate for radiation therapy
- •Karnofsky performance status (KPS) \>= 60
- •Diagnosed with uveal melanoma either clinically or pathologically on biopsy
- •Uveal melanoma of one eye only
- •Localized uveal melanoma, with no evidence of metastasis
- •Women of childbearing potential must have a negative urine or serum pregnancy test within 14 days prior to enrollment
Exclusion Criteria
- •Tumor thickness more than 14 mm as measured by ultrasound
- •Active collagen vascular disease
- •Any contraindication to intravitreal injections including: elevated intraocular pressure, ocular or periocular infection, active intraocular inflammation, or other determined by treating physician
- •Known allergic reactions to components of intravitreal Aflibercept
- •Patients with known hypercoagulable syndromes
- •Prior radiation to the eye or brain
- •Life expectancy less than 6 months
- •Blind in both eyes
- •Patients unable to receive contrast enhanced brain magnetic resonance imaging (MRI)
- •Deaf in both ears
Arms & Interventions
A. Stereotactic body radiation therapy, ziv-aflibercept
Patients undergo stereotactic body radiation therapy over 5 fractions every other week day during days 1-10. Patients then receive ziv-aflibercept IVI on the last day of radiation therapy and then every 2 months for up to 2 years in the absence of disease progression or unacceptable toxicity.
Intervention: Stereotactic Body Radiation Therapy
B. Stereotactic body radiation therapy, ziv-aflibercept
Patients undergo stereotactic body radiation therapy as in arm A. Patients then receive ziv-aflibercept IVI on the last day of radiation therapy and then every 4 months for up to 2 years in the absence of disease progression or unacceptable toxicity.
Intervention: Ziv-Aflibercept
Outcomes
Primary Outcomes
Incidence of Adverse Events
Time Frame: Up to approximately 6 months
Percent of patients who experience Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade ≥3 toxicity related to SRT and/or intravitreal Aflibercept.
Secondary Outcomes
- Radiation Maculopathy Rate Defined as Ophthalmoscopic Detection of Macular Edema Perivascular Sheathing(At 2 years)
- Radiation Papillopathy Rate Defined as Ophthalmoscopic Detection of Peripapillary Encircling Nerve Fiber Layer Infarction(At 2 years)