Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma

Inclusion Criteria

• •Histologically/cytologically confirmed melanoma that is metastatic/unresectable
• •Residual, recurrent, or metastatic disease by radiographic examination. Measurable disease (at least 1 lesion in at least 1 dimension (longest diameter) as \>20mm with conventional techniques or \>10mm with spiral CT scan, within 4 weeks prior to registration
• •No prior therapy or 1 prior treatment (cytokine/chemotherapy/combination) for metastatic disease allowed. Patients should not take valproic acid, another histone deacetylase inhibitor, for at least 2 weeks prior to enrollment. At least 4 weeks from prior therapy to be eligible or 6 weeks if last regimen included BCNU or mitomycin C
• •Age\>=18 years
• •Life expectancy \>=3 months.
• •ECOG\<2 (Karnofsky ≥60%)
• •Leukocytes \>3,000/mcL
• •Absolute neutrophil count \>1,500/mcL
• •Platelets \>100,000/mcL
• •Total bilirubin within institutional limits
• •AST/ALT≤2.5Xinstitutional ULN
• •Creatinine within institutional limits OR creatinine clearance \>60mL/min/1.73 m2 if creatinine levels above institutional limits
• •Eligibility of patients taking medications with potential to affect activity/PK of Vorinostat will be determined by PI
• •Must not use concomitant steroids except topical/inhaled use
• •Vorinostat effects on developing human fetus are unknown. Women of childbearing potential (WOCBP) and sexually active males must agree to use accepted/effective contraception method prior to study entry and for duration of the study
• •Ability to understand/willingness to sign written informed consent
• •Must have paraffin block of tumor tissue available for future studies