Melanoma Clinical Trial

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

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.

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Full 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.

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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
Patients have hypersensitivity to intravitreal Aflibercept
Patients is on or within 1 month of systemic anti-VEGF treatment
Patients who are candidates for brachytherapy
Patients for whom enucleation is standard of care

Pregnancy or active breastfeeding. Sexually active men or women of childbearing potential who are unwilling to practice adequate contraception prior to the initial dose/start of the first treatment, during the study, and for at least 3 months after the last dose. Adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly

Contraception is not required for men with documented vasectomy
Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of childbearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

3

Study ID:

NCT03712904

Recruitment Status:

Active, not recruiting

Sponsor:

Sidney Kimmel Cancer Center at Thomas Jefferson University

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There is 1 Location for this study

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Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

3

Study ID:

NCT03712904

Recruitment Status:

Active, not recruiting

Sponsor:


Sidney Kimmel Cancer Center at Thomas Jefferson University

How clear is this clinincal trial information?

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