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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Study ID
NCT03712904
Phase
PHASE2
Status
Terminated

Conditions

  • Uveal Melanoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Stereotactic Body Radiation Therapy — RADIATION
    Undergo radiation
  • Ziv-Aflibercept — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
Aug 9, 2019
Status verified
Sep 2025
Primary completion
Sep 20, 2022
Completion
Dec 23, 2022

Study Design

Enrollment
3 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Incidence of Adverse Events [ Time Frame: Up to approximately 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-

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Sidney Kimmel Cancer Center at Thomas Jefferson University· Philadelphia, PA

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