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.
PRIMARY OBJECTIVES:
SECONDARY OBJECTIVES:
TERTIARY OBJECTIVES:
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.
| 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 Identifier | NCT02068586 |
| Sponsor | Sidney Kimmel Cancer Center at Thomas Jefferson University |
| Last Modified on | 18 August 2022 |
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