PXD101 in Treating Patients With Acute Myeloid Leukemia

Exclusion Criteria

• •Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
• •Patients may not be receiving any other investigational agents
• •Patients with known central nervous system (CNS) disease should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
• •History of allergic reactions attributed to compounds of similar chemical or biologic composition to PXD101
• •Patients may not have had prior treatment with another HDAC inhibitor within 1 week of initiation of therapy with PXD101; patients receiving valproic acid should stop this medication at least 1 week prior to therapy with PXD101
• •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that could compromise compliance with study requirements
• •Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with PXD101
• •HIV-positive patients are ineligible
• •Patients with a marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration of a QTc interval 500 msec), Long QT Syndrome, or the required use of concomitant medication on PXD101 infusion days that may cause Torsade de Pointes (including disopyramide, dofetilide, ibutilide, procainamide, quinidine, sotalol, bepridil, amiodarone, arsenic trioxide, cisapride, lidoflazine, clarithromycin, erythromycin, halofantrine, pentamidine, sparfloxacin, domperidone, droperidol, chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, and methadone)
• •Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension, congestive heart failure related to primary cardiac disease, a condition requiring anti-arrhythmic therapy, ischemic or severe valvular heart disease, or a myocardial infarction within 6 months prior to trial entry