Belinostat in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery

Inclusion Criteria

• Histologically or cytologically confirmed hepatocellular carcinoma that is not amenable to curative resection
• Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques OR as ≥ 10 mm with MRI or spiral CT scan
• No known brain metastases
• No clinical ascites or encephalopathy
• Life expectancy > 12 weeks
• ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
• WBC ≥ 3,000/mm³
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Bilirubin ≤ 1.7 mg/dL
• Albumin ≥ 2.8 mg/dL
• ALT ≤ 5.0 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 6 times ULN
• Prothrombin time ≤ 4 sec above ULN
• Creatinine ≤ 1.6 mg/dL
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients use effective contraception
• No Child's-Pugh's grading Class C hepatic impairment
• No history of allergic reaction attributed to compounds of similar chemical or biologic composition to PXD101
• No marked baseline prolongation of QT/QTc interval, including the following:
• Repeated demonstration of a QTc interval > 500 msec
• Long QT Syndrome
• No ongoing or active infection
• No significant cardiovascular disease, including any of the following:
• Unstable angina pectoris
• Uncontrolled hypertension
• Congestive heart failure related to primary cardiac disease
• Condition requiring anti-arrhythmic therapy
• Ischemic or severe valvular heart disease
• Myocardial infarction within the past 6 months
• No psychiatric illness or social situation that would preclude study compliance
• No other uncontrolled illness
• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
• 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 concurrent participation in another investigational study
• No other concurrent investigational agents
• No other concurrent anticancer therapy
• No concurrent use of any of the following:
• Disopyramide
• Dofetilide
• Ibutilide
• Procainamide
• Quinidine
• Sotalol
• Bepridil
• Amiodarone
• Arsenic trioxide
• Cisapride
• Calcium channel blockers (e.g., lidoflazine)
• Clarithromycin
• Erythromycin
• Halofantrine
• Pentamidine
• Sparfloxacin
• Domperidone
• Droperidol
• Chlorpromazine
• Haloperidol
• Mesoridazine
• Thioridazine
• Pimozide
• Methadone