Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma

Inclusion Criteria:

• Life expectancy at least 3 months
• Bilirubin normal
• Creatinine normal OR creatinine clearance ≥ 60 mL/min
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study compliance
• No history of allergic reaction attributed to compounds of similar chemical or biological composition to suberoylanilide hydroxamic acid
• No other uncontrolled illness
• Prior adjuvant interferon for stage II or stage III disease allowed
• Prior vaccine therapy as adjuvant therapy or for metastatic disease allowed
• No more than 1 prior cytokine and/or chemotherapy regimen for metastatic disease
• No concurrent prophylactic hematopoietic colony-stimulating factors except erythropoietin
• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
• No concurrent steroids except topical or inhaled steroids
• More than 4 weeks since prior radiotherapy and recovered
• At least 2 weeks since prior valproic acid
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No other concurrent investigational agents
• No other concurrent anticancer agents or therapies
• Histologically or cytologically confirmed melanoma (metastatic or unresectable disease)

• The following melanoma types are allowed:

  • Cutaneous
  • Mucosal
  • Ocular
  • Unknown primary
• Evidence of residual, recurrent, or metastatic disease by radiographic examination
• Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan (tumor lesions located within a previously irradiated volume that are the only site of measurable disease must have clear evidence of progression)
• WBC >= 3,000/mm^3
• Absolute neutrophil count >= 1,500/mm^3
• Platelet count >= 100,000/mm^3
• AST and ALT =< 2.5 times upper limit of normal
• ECOG 0-2 OR Karnofsky 60-100%
• No known brain metastases