NCT00121225

Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma

A Phase II Study of Vorinostat in Patients With Advanced Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well vorinostat works in treating patients with metastatic or unresectable melanoma. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Detailed description

PRIMARY OBJECTIVE: I. Determine the objective response rate in patients with metastatic or unresectable melanoma treated with vorinostat. SECONDARY OBJECTIVES: I. Determine time to progression in patients treated with this drug. II. Determine the utility of HP1 and/or macro H2A nuclear foci as biomarkers of response in patients treated with this drug. III. Correlate the presence of 72R or 72P variant p53 polymorphisms with response and time to progression in patients treated with this drug. IV. Determine gene expression profiles that may predict response to this drug and gene expression changes that occur after treatment with this drug in these patients. OUTLINE: This is a multicenter study. Patients receive oral vorinostat once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for 4 weeks and then every 3 months thereafter.

Conditions

• Ciliary Body and Choroid Melanoma, Medium/Large Size
• Extraocular Extension Melanoma
• Iris Melanoma
• Uveal Melanoma
• Recurrent Intraocular Melanoma
• Recurrent Melanoma
• Stage IV Melanoma

Interventions

Type	Name	Description
DRUG	vorinostat	Patients will receive vorinostat by mouth once a day for 4 weeks. Treatment may repeat every 4 weeks for as long as benefit is shown. Patients will be evaluated for 4 weeks and every 3 months thereafter.

Timeline

• Start date: 2005-09-01
• Primary completion: 2009-03-01
• Completion: 2013-06-01
• First posted: 2005-07-21
• Last updated: 2019-01-29
• Results posted: 2014-10-03

Locations

5 sites across 2 countries: United States, Canada