NCT01587352

Vorinostat in Treating Patients With Metastatic Melanoma of the Eye

A Phase 2 Study of Vorinostat (NSC 701852) in Metastatic Uveal Melanoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Metastatic Uveal Melanoma
• Stage IV Uveal Melanoma AJCC v7

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Vorinostat	Given PO

Timeline

• Start date: 2012-05-29
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2012-04-30
• Last updated: 2026-04-13

Locations

3 sites across 1 country: United States