A Phase II Study Of Depsipeptide, A Histone Deacetylase Inhibitor, In Relapsed Or Refractory Mantle Cell Or Diffuse Large Cell Non-Hodgkin's Lymphoma

Study start date: January 1, 2004

DISEASE CHARACTERISTICS: Histologically confirmed aggressive B-cell non-Hodgkin's lymphoma of 1 of the following cellular types: Diffuse large cell Mantle cell Burkitt's Relapsed or refractory disease No more than 2 prior regimen for patients with refractory disease Any number of prior therapies (including peripheral blood stem cell or bone marrow transplantation) allowed for patients with relapsed disease provided there was an objective response to the most recent therapy Measurable disease At least 1 lesion ≥ 1.5 cm in diameter No transformed lymphoma No CNS lymphoma Ineligible for, refused, or relapsed after stem cell transplantation PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Hematopoietic Absolute neutrophil count ≥ 1,000/mm^3 (500/mm^3 in patients with extensive bone marrow involvement [> 50%] or hypersplenism with palpable splenomegaly) Platelet count ≥ 75,000/mm^3 (50,000/mm^3 in patients with extensive bone marrow involvement or hypersplenism with palpable splenomegaly) Hepatic Bilirubin ≤ upper limit of normal (ULN) Alkaline phosphatase ≤ 2 times ULN AST ≤ 2 times ULN Renal Creatinine ≤ ULN Cardiovascular QTc < 500 msec by ECG Cardiac function ≥ 50% by MUGA No prior serious ventricular arrhythmia No New York Heart Association class III or IV congestive heart failure No significant cardiac hypertrophy by ECG No other significant cardiac disease Pulmonary No chronic obstructive pulmonary disease Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No active infection No diabetes No other uncontrolled serious medical condition PRIOR CONCURRENT THERAPY: Chemotherapy Prior cumulative doxorubicin dose < 450 mg/m^2 Prior cumulative mitoxantrone dose < 112 mg/m^2 Prior doxorubicin equivalent dose < 450 mg/m^2 (for patients who have previously received both doxorubicin and mitoxantrone) Other Recovered from all prior therapy No prior histone deacetylase inhibitor therapy No concurrent medication associated with QTc prolongation, such as dolasetron Concurrent hydrochlorothiazide, furosemide, or other diuretics allowed provided patient is on concurrent potassium chloride supplementation