Vorinostat in Treating Patients With Metastatic Melanoma of the Eye

Status Active, not recruiting

Clinical Trial Summary

This phase II trial studies how well vorinostat works in treating patients with melanoma of the eye that has spread to other parts of the body (metastatic). Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Clinical Trial Description

PRIMARY OBJECTIVE: I. To determine the overall objective response rate (RR) to vorinostat in patients with metastatic uveal melanoma. SECONDARY OBJECTIVES: I. Overall survival (OS). II. Progression free survival (PFS). III. To determine the tolerability of vorinostat in patients with metastatic uveal melanoma. EXPLORATORY OBJECTIVES: I. To correlate clinical outcome with changes in histone acetylation status by immunohistochemistry. II. To correlate clinical outcome with changes in known proliferation and apoptotic markers including Ki67 by immunohistochemistry and BIM, survivin, c-myc, Mcl-1, cleaved PARP, gamma-H2AX and RAD51 by western blot. III. To assess for changes in pathways such as the MAPK pathway with treatment. IV. To describe the evolution of circulating cell-free, tumor-derived deoxyribonucleic acid (DNA) levels measured by pyrophosphorolysis activated polymerization (PAP) in plasma of patients under treatment for metastatic uveal melanoma. V. To correlate overall objective RR with GNAQ, GNA11, SF3B1 and BAP1 mutational status. OUTLINE: Patients receive vorinostat orally (PO) twice daily (BID) for 3 days weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 12 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01587352
Study type	Interventional
Source	National Cancer Institute (NCI)
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	May 29, 2012
Completion date	December 31, 2024

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT03068624` - Autologous CD8+ SLC45A2-Specific T Lymphocytes With Cyclophosphamide, Aldesleukin, and Ipilimumab in Treating Patients With Metastatic Uveal Melanoma	Phase 1
Recruiting	`NCT04728633` - Transarterial Chemoembolization for the Treatment of Uveal Melanoma With Liver Metastases	Phase 2
Recruiting	`NCT05987332` - IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma	Phase 2/Phase 3
Completed	`NCT01551459` - A Phase II Study of Sunitinib Versus Dacarbazine in the Treatment of Patients With Metastatic Uveal Melanoma	Phase 2
Active, not recruiting	`NCT00986661` - A Study to Assess PV-10 Chemoablation of Cancer of the Liver	Phase 1
Completed	`NCT01585194` - Nivolumab and Ipilimumab in Treating Patients With Metastatic Uveal Melanoma	Phase 2
Withdrawn	`NCT01328106` - Efficacy and Safety Study of GSK1120212, a MEK Inhibitor, in Subjects With Uveal Melanoma	Phase 2
Recruiting	`NCT05075993` - Study of LVGN3616 and LVGN6051±LVGN7409 in Combination With Nab-Paclitaxel or Bevacizumab and Cyclophosphamide in Metastatic Solid Tumors	Phase 1
Active, not recruiting	`NCT04552223` - Nivolumab Plus Relatlimab in Patients With Metastatic Uveal Melanoma	Phase 2
Recruiting	`NCT05607095` - Pilot Trial of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Patients With Metastatic Uveal Melanoma	Phase 1
Active, not recruiting	`NCT03472586` - Ipilimumab and Nivolumab With Immunoembolization in Treating Participants With Metastatic Uveal Melanoma in the Liver	Phase 2
Active, not recruiting	`NCT03025256` - Intravenous and Intrathecal Nivolumab in Treating Patients With Leptomeningeal Disease	Phase 1
Terminated	`NCT04879017` - FHD-286 in Subjects With Metastatic Uveal Melanoma	Phase 1
Terminated	`NCT01814046` - Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Ocular Melanoma	Phase 2
Recruiting	`NCT03947385` - Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions	Phase 1/Phase 2
Active, not recruiting	`NCT03865212` - Modified Virus VSV-IFNbetaTYRP1 in Treating Patients With Stage III-IV Melanoma	Phase 1
Active, not recruiting	`NCT05022901` - An Open-Label Expanded Access Study of the Melphalan/Hepatic Delivery System (HDS) in Patients With Hepatic Dominant Ocular Melanoma	Phase 3
Recruiting	`NCT05282901` - Efficacy and Safety of Pembrolizumab in Combination With Lenvatinib in Metastatic Uveal MElanoma Patients (PLUME)	Phase 2
Recruiting	`NCT05415072` - A Phase I/II Study of DYP688 in Patients With Metastatic Uveal Melanoma and Other GNAQ/11 Mutant Melanomas	Phase 1/Phase 2
Active, not recruiting	`NCT04720417` - Defactinib and VS-6766 for the Treatment of Patients With Metastatic Uveal Melanoma	Phase 2