Adjuvant Sunitinib or Valproic Acid in High-Risk Patients With Uveal Melanoma
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|ClinicalTrials.gov Identifier: NCT02068586|
Recruitment Status : Recruiting
First Posted : February 21, 2014
Last Update Posted : March 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase ll Study of Adjuvant Sunitinib or Valproic Acid in High-Risk Patients With Uveal Melanoma|
|Actual Study Start Date :||November 19, 2014|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2021|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02068586
|Contact: Takami Sato, MD||215-955-8874|
|Contact: Melanoma Research Group||215-955-9980|
|United States, Pennsylvania|
|Sidney Kimmel Cancer Center at Thomas Jefferson University||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Takami Sato, MD 215-955-8874|
|Contact: Melanoma Research Group|
|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|