FR901228 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Condition: Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Mantle Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, Mantle-Cell; Lymphoma, Large B-Cell, Diffuse; Recurrence
Intervention: romidepsin
Intervention description: Given IV
Intervention MeSH terms: Romidepsin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      FR901228 may stop the growth of cancer cells by blocking some of the enzymes needed for cell
      to grow and by blocking blood flow to the cancer. This phase II trial is studying how well
      FR901228 works in treating patients with relapsed or refractory non-Hodgkin's lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed aggressive B-cell non-Hodgkin's lymphoma of 1 of the
             following subtypes:

               -  Mantle cell lymphoma

               -  Diffuse large cell lymphoma

               -  (Ineligible for or unwilling to undergo stem cell transplantation)

          -  Relapsed or refractory disease:

               -  Any number of prior therapies allowed for relapsed disease, including peripheral
                  blood stem cell or bone marrow transplantation

               -  No more than 2 prior regimens, excluding monotherapy with monoclonal antibody or
                  radiotherapy, for refractory disease

          -  Measurable disease, defined as >= 1 lesion >= 1.5 cm in the longest diameter

          -  No transformed lymphoma, defined as the transformation of a low-grade lymphoma,
             including follicular lymphoma or small lymphocytic lymphoma, to a high-grade lymphoma
             (e.g., diffuse large cell lymphoma)

          -  ECOG performance status 0-2

          -  Absolute neutrophil count >= 1,000/mm^3 OR >= 500/mm^3 if extensive bone marrow
             involvement (> 50%) or hypersplenism with palpable splenomegaly

          -  Platelet count >= 75,000/mm^3 OR >= 50,000/mm^3 if extensive bone marrow involvement
             (> 50%) or hypersplenism with palpable splenomegaly

          -  Bilirubin normal

          -  Alkaline phosphatase =< 2 times upper limit of normal (ULN)

          -  AST =< 2 times ULN

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No significant cardiac disease, including New York Heart Association class III-IV
             congestive heart failure

          -  No history of serious ventricular arrhythmia

          -  QTc < 500 msec

          -  No evidence of cardiac hypertrophy on ECG

          -  No known HIV positivity

          -  No other uncontrolled serious medical condition or active infection (e.g., chronic
             obstructive pulmonary disease, diabetes)

          -  Recovered from prior therapy

          -  No prior doxorubicin hydrochloride >= 450 mg/m^2 or mitoxantrone >= 112 mg/m^2
             (Patients who received both mitoxantrone and doxorubicin hydrochloride should have a
             "doxorubicin equivalent dose" < 450 mg/m^2

          -  No prior therapy with a histone deacetylase inhibitor

          -  No concurrent dexamethasone or prednisone except for refractory nausea/vomiting

          -  No concurrent drugs associated with QTc prolongation (e.g., dolasetron mesylate)

          -  Concurrent hydrochlorothiazide, furosemide, or other diuretics allowed provided
             patient is receiving potassium chloride supplementation (No supplementation needed if
             switched to a potassium-conserving diuretic)

          -  No CNS lymphoma

          -  Creatinine normal

          -  Cardiac function >= 50% by MUGA