Recurrent Melanoma Clinical Trial
Official title:
A Phase II Study of Vorinostat in Patients With Advanced Melanoma
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.
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.
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