Adjuvant Sunitinib or Valproic Acid in High-Risk Patients With Uveal Melanoma
|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||Drug: Sunitinib Drug: Valproic Acid||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 ]
- 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 ]
- Tolerability [ Time Frame: 6 months ]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: Melanoma Research Group||215-955-9980|
|United States, Pennsylvania|
|Thomas Jefferson University||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Takami Sato, MD|
|Contact: Melanoma Research Group|
|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|