A Phase II Study of Vorinostat in Patients With Advanced Melanoma
I. Determine the objective response rate in patients with metastatic or unresectable
melanoma treated with vorinostat.
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
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate assessed by Response Evaluation Criteria for Solid Tumors (RECIST)
Up to 5 years
Princess Margaret Hospital Phase 2 Consortium
United States: Food and Drug Administration
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|