Vorinostat in Patients With Class 2 High Risk Uveal Melanoma
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|ClinicalTrials.gov Identifier: NCT03022565|
Recruitment Status : Recruiting
First Posted : January 16, 2017
Last Update Posted : January 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Uveal Melanoma||Drug: Vorinostat||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Proof of Concept Study of Vorinostat, A Histone Deacetylase Inhibitor, in Patients With Class 2 High Risk Uveal Melanoma|
|Estimated Study Start Date :||July 2019|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2026|
Study participants 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.
Other Name: Zolinza
- 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.
- 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.
- Global histone acetylation levels in peripheral blood mononuclear cells (PBMCs) before and after Vorinostat therapy. [ Time Frame: From Baseline to 15 Days of Protocol Therapy, Up to 4 Weeks ]Global histone acetylation levels in peripheral blood mononuclear cells (PBMCs) will be measured at baseline (Day 1, before Vorinostat treatment) and post-treatment (day 15 after completion of Vorinostat therapy).
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): NCT03022565
|United States, Florida|
|University of Miami||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Andrea Pena 305-243-7592 email@example.com|
|Contact: Lynn Feun, MD 305-243-6606 firstname.lastname@example.org|
|Principal Investigator: Lynn Feun, MD|
|Principal Investigator:||Lynn Feun, MD||University of Miami|