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 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

Exclusion Criteria

• Chemotherapy/radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering study
• May not be receiving any other investigational agents
• Known brain metastases
• History of allergic reactions attributed to compounds of similar chemical/biologic composition to Vorinostat
• Uncontrolled intercurrent illness including but not limited to ongoing/active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant women excluded because Vorinostat is a HDAC inhibitor agent with potential for teratogenic or abortifacient effects
• HIV-positive patients receiving combination antiretroviral therapy are ineligible because of potential for PK interactions with Vorinostat