PXD101 as Second-Line Therapy in Treating Patients With Malignant Mesothelioma of the Chest That Cannot Be Removed By Surgery
Advanced Malignant Mesothelioma, Epithelial Mesothelioma, Recurrent Malignant Mesothelioma
About this trial
This is an interventional treatment trial for Advanced Malignant Mesothelioma
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed malignant pleural mesothelioma (MPM) of any of the following subtypes: Epithelial Sarcomatoid Mixed Have received only 1 prior systemic chemotherapy regimen for advanced mesothelioma Prior intrapleural cytotoxic agents (including bleomycin) not considered systemic chemotherapy Patients who are not candidates for combination chemotherapy are eligible even if they have not received prior chemotherapy Unresectable disease Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan The sole site of measurable disease must not be located within the radiotherapy port No known brain metastases ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100% Life expectancy > 3 months WBC >= 3,000/mm^3 Absolute neutrophil count >= 1,500/mm^3 Platelet count >= 100,000/mm^3 Bilirubin normal AST/ALT =< 2.5 times upper limit of normal Creatinine normal OR creatinine clearance >= 50 mL/min Not pregnant or nursing Negative pregnancy test Fertile patients must use effective double-barrier contraception for 1 week before, during, and for >= 2 weeks after completion of study treatment No history of allergic reactions attributed to compounds of similar chemical or biologic composition to PXD101 No symptomatic congestive heart failure No congestive heart failure related to primary cardiac disease No unstable angina pectoris No cardiac arrhythmia No condition requiring anti-arrhythmic therapy No uncontrolled hypertension No myocardial infarction within the past 6 months No ischemic or severe valvular heart disease No ongoing or active infection No marked baseline prolongation of QT/QTc interval No repeated QTc interval > 500 msec No long QT syndrome No other significant cardiovascular disease No other uncontrolled intercurrent illness No psychiatric illness or social situation that would preclude study compliance Recovered from prior therapy No prior valproic acid or other known histone deacetylase (HDAC) inhibitor More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) More than 3 weeks since prior radiation therapy No concurrent medication that may cause torsade de pointes No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent investigational agents No other concurrent anticancer agents or therapies
Sites / Locations
- City of Hope
Arms of the Study
Arm 1
Experimental
Treatment (belinostat)
Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.