Phase II Study of PXD101 (NSC-726630) in Relapsed and Refractory Aggressive B-Cell Lymphomas

Transformed non-Hodgkin's lymphoma or relapsed/refractory B-cell lymphoma of the following histologic subtypes (diffuse large, Burkitt's or Burkitt-like, or primary mediastinal); patients being registered to this study at first relapse must not be suitable for stem cell transplantation; must have a unilateral or bilateral bone marrow aspiration and biopsy w/in 42 days prior to registration; adequate sections from the original biopsy specimen must be made available; >= age 18; PS=0-2; must have bidimensionally measurable disease; may have had up to 5 prior chemotherapy regimens; Patients should not have taken valproic acid, or any other histone deacetylase inhibitor, for at least 14 days prior to registration; must have recovered from any toxicities related to therapies prior to registration; ANC>=1,500, platelets>=100,000, leukocytes >= 3,000, bilirubin>=IULN, SGOT/SGPT < 5 X IULN (for subjects w/ liver involvement) or SGOT/SGPT < 2.5 X IULN (for subjects w/o liver involvement), serum creatinine < 2 X IULN or measured creatinine clearance >= 60 mL/min; must have an EKG w/ no significant abnormalities w/in 42 days prior to registration; must consent to the blood specimen submission; if participating in tissue sample submission, must consent to its procedures; must have had a chest x-ray or CT scan of the chest and a CT scan of the abdomen and pelvis w/in 28 days prior to registration; must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to PXD101; must not be taking concomitant medication that may cause Torsade de Pointes (i.e. prolongation of the QT interval > 500 msec); no prior malignancy except for adequately treated basal cell or squamous cell of the skin, in situ cervical cancer, or other cancer for which the patient is disease free for >= 5 years; must not have had major surgery w/in 28 days prior to registration or radiotherapy w/in 14 days prior to registration; must not be a pregnant or nursing female; must not have known HIV or AIDS syndrome; must not have clinical evidence of CNS involvement by lymphoma; must not have significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension, congestive heart failure related to primary cardiac disease, any condition requiring anti-arrhythmic therapy, ischemic or valvular heart disease, or a myocardial infarction w/in the past 6 months; must not have Long QT Syndrome or marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration of a QTc interval > 500 msec); must not have clinical evidence of severe peripheral vascular disease, diabetic ulcers or venous stasis ulcers, or history of deep venous or arterial thrombosis w/in the last 3 months.