Belinostat in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer
About this trial
This is an interventional treatment trial for Adult Primary Hepatocellular Carcinoma
Eligibility Criteria
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
Sites / Locations
- University of Wisconsin Hospital and Clinics
- Cancer Therapeutics Research Group
Arms of the Study
Arm 1
Experimental
Treatment (enzyme inhibitor therapy)
Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.