Adjuvant Sunitinib or Valproic Acid in High-Risk Patients With Uveal Melanoma
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.
Ciliary Body and Choroid Melanoma, Medium/Large Size
Ciliary Body and Choroid Melanoma, Small Size
Stage I Intraocular Melanoma
Stage IIA Intraocular Melanoma
Stage IIB Intraocular Melanoma
Stage IIIA Intraocular Melanoma
Stage IIIB Intraocular Melanoma
Stage IIIC Intraocular Melanoma
Drug: Valproic Acid
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Phase ll Study of Adjuvant Sunitinib or Valproic Acid in High-Risk Patients With Uveal Melanoma|
- Overall survival [ Time Frame: Time of definitive treatment of the primary tumor until death from any cause, assessed at 2 years ] [ Designated as safety issue: No ]
- Relapse-free survival [ Time Frame: Time of definitive treatment of the primary tumor until confirmed metastatic relapse or death from any cause, assessed at 2 years ] [ Designated as safety issue: No ]
- Tolerability [ Time Frame: 6 months ] [ Designated as safety issue: No ]Defined as the proportion of patients able to complete 6 months of treatment, including those who underwent dose reduction
|Study Start Date:||November 2014|
|Estimated Primary Completion Date:||February 2019 (Final data collection date for primary outcome measure)|
Patients receive sunitinib malate PO daily for 6 months in the absence of disease progression or unacceptable toxicity
Experimental: Valproic acid
Patients receive valproic acid PO daily for 6 months in the absence of disease progression or unacceptable toxicity
Drug: Valproic Acid
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.
- 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.
- To confirm the safety and tolerability of 6 months of adjuvant sunitinib and adjuvant valproic acid in patients with high-risk uveal melanoma.
- To assess the quality of life during the adjuvant treatment.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02068586
|Contact: Takami Sato, MD||215-955-8874|
|Contact: Mary Ann Laudadio, RN||215-955-9980||MaryAnn.Laudadio@jefferson.edu|
|United States, Pennsylvania|
|Thomas Jefferson University||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Takami Sato, MD|
|Contact: Tracey Newhall, RN Tracey.Newhall@jefferson.edu|
|Sub-Investigator: Jianqing Lin, MD|
|Sub-Investigator: Kendra Feeney, MD|
|Sub-Investigator: Michael Mastrangelo, MD|
|Sub-Investigator: Carol Shields, MD|
|Sub-Investigator: Jerry Shields, MD|
|Principal Investigator:||Takami Sato, MD||Thomas Jefferson University|