Adjuvant Sunitinib or Valproic Acid in High-Risk Patients With Uveal Melanoma

  • STATUS
    Recruiting
  • participants needed
    150
  • sponsor
    Sidney Kimmel Cancer Center at Thomas Jefferson University
Updated on 18 August 2022

Summary

This randomized phase II trial studies how well sunitinib malate or valproic acid works in preventing high-risk uveal (eye) melanoma from spreading to other parts of the body. Sunitinib malate may stop the transmission of growth signals into tumor cells and prevents these cells from growing. Valproic acid may change the expression of some genes in uveal melanoma and suppress tumor growth.

Description

PRIMARY OBJECTIVES:

  1. To assess the efficacy of adjuvant sunitinib malate or adjuvant valproic acid used for 6 months to improve overall survival (OS) at 2 years in patients with high-risk uveal melanoma.

SECONDARY OBJECTIVES:

  1. To assess the efficacy of adjuvant sunitinib malate and adjuvant valproic acid used for 6 months in preventing the development of distal metastases (relapse-free survival, RFS) in patients with high-risk uveal melanoma.
  2. To confirm the safety and tolerability of 6 months of adjuvant sunitinib and adjuvant valproic acid in patients with high-risk uveal melanoma.
  3. To assess the quality of life during the adjuvant treatment.

TERTIARY OBJECTIVES:

  1. To determine whether blood myeloid-derived suppressor cells (MDSCs) concentration and other inflammatory cytokines correlates with OS and RFS.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive sunitinib malate orally (PO) daily for 6 months in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive valproic acid PO daily for 6 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Details
Condition Ciliary Body and Choroid Melanoma, Medium/Large Size, Ciliary Body and Choroid Melanoma, Small Size, Iris Melanoma, Stage I Intraocular Melanoma, Stage IIA Intraocular Melanoma, Stage IIB Intraocular Melanoma, Stage IIIA Intraocular Melanoma, Stage IIIB Intraocular Melanoma, Stage IIIC Intraocular Melanoma
Treatment Sunitinib, valproic acid
Clinical Study IdentifierNCT02068586
SponsorSidney Kimmel Cancer Center at Thomas Jefferson University
Last Modified on18 August 2022

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