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

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Brief Title

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

Official Title

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

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Incidence of grade 3 or higher toxicity according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Secondary Outcome

 Radiation maculopathy rate defined as ophthalmoscopic detection of macular edema perivascular sheathing

Condition

Uveal Melanoma

Intervention

Stereotactic Body Radiation Therapy

Study Arms / Comparison Groups

 A. Stereotactic body radiation therapy, ziv-aflibercept
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Radiation

Estimated Enrollment

36

Start Date

August 9, 2019

Completion Date

July 2024

Primary Completion Date

October 9, 2023

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
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Wenyin Shi, MD, PhD, (215) 955-6702, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03712904

Organization ID

18P.457


Responsible Party

Sponsor

Study Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

Collaborators

 Regeneron Pharmaceuticals

Study Sponsor

Wenyin Shi, MD, PhD, Principal Investigator, Sidney Kimmel Cancer Center at Thomas Jefferson University


Verification Date

August 2021