Clinical Trial: Vorinostat in Patients With Class 2 High Risk Uveal Melanoma

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Proof of Concept Study of Vorinostat, A Histone Deacetylase Inhibitor, in Patients With Class 2 High Risk Uveal Melanoma

Brief Summary: This proof-of-concept study will evaluate the ability of vorinostat to induce the transformation of Class 2 uveal melanoma cells into a cell phenotype that resembles normal melanocytes.

Detailed Summary: This is a proof of concept, single-center, open-label study of an FDA-approved drug, vorinostat, a Histone deacetylase (HDAC) inhibitor, for patients with Class 2, high-risk uveal melanoma with localized eye tumors. The primary aim is to test if vorinostat can transform aggressive class 2 uveal melanoma cells into cells that look more like normal melanocytes as observed in the laboratory. Uveal melanoma patients that meet the inclusion criteria outlined in this protocol will be consented and asked to provide a fine needle aspiration (FNA) biopsy of their uveal melanoma primary tumor. This biopsy will be submitted for gene expression analysis to determine the phenotype of the tumor. A total of 10 patients who meet the criteria of Class 2 uveal melanoma and no radiologic evidence of metastases will be treated with 400 mg of vorinostat daily for 15 days. On Day 15, patients will be asked to provide a second FNA biopsy prior to receiving the standard of care local definitive therapy either plaque radiotherapy or enucleation.
Sponsor: Nicolas Acquavella

Current Primary Outcome:

• Degree of transformation from a class 2 phenotype into a cell phenotype that resembles normal melanocytes. [ Time Frame: From Baseline to 15 Days of Protocol Therapy, Up to 4 Weeks ]
  The investigators will analyze gene expression results from fine needle aspirate biopsies performed at baseline prior to vorinostat therapy and post-treatment (on Day 15, after the planned 15 days of vorinostat therapy).
• Proportion of patients whose tumors transformed from a class 2 phenotype into a cell phenotype that resembles normal melanocytes. [ Time Frame: From Baseline to 15 Days of Protocol Therapy, Up to 4 Weeks ]
  Through gene expression analysis, the investigators will determine the proportion of patients whose tumors transformed from a Class 2 phenotype into a cell phenotype that resembles normal melanocytes.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Toxicity During Protocol Therapy [ Time Frame: Up to 1 Month Post-Treatment Completion ]
  Rate of adverse events (AEs) and serious adverse events (SAEs) experienced by study participants during Vorinostat therapy and up to one month after Vorinostat treatment completion.
• Tumor size before and after Vorinostat therapy [ Time Frame: From Baseline to 15 Days of Protocol Therapy, Up to 4 Weeks ]
  Tumor size will be determined before and after Vorinostat therapy by B-Scan ultrasonography.
• Recurrence-free survival (RFS) [ Time Frame: Up to 5 Years Post-Treatment Completion ]
  Recurrence-Free Survival (RFS) in Study Participants. RFS is defined as the duration of time from start of treatment to time of disease recurrence or death, whichever occurs first.
• Overall survival (OS) [ Time Frame: Up to 5 Years Post-Treatment Completion ]
  Overall Survival (OS) in Study Participants. OS is defined as the length of time from date of start of Vorinostat treatment to death.
• Disease Specific Survival (DSS) [ Time Frame: Up to 5 Years Post-Treatment Completion ]
  Disease Specific Survival (DSS) in Study Participants. DSS is defined as the time from start of Vorinostat treatment to death due to disease.

Original Secondary Outcome: Same as current

Information By: University of Miami

Dates:
Date Received: December 21, 2016
Date Started: May 2017
Date Completion: May 2024
Last Updated: April 27, 2017
Last Verified: April 2017