PXD101 in Treating Patients With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma
Condition: Recurrent Adult Burkitt Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma
MeSH terms: Burkitt Lymphoma; Lymphoma; Lymphoma, Large B-Cell, Diffuse; Recurrence
Intervention: belinostat
Intervention description: Given IV
Intervention MeSH terms: Belinostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well PXD101 works in treating patients with relapsed or
      refractory aggressive B-cell non-Hodgkin's lymphoma. PXD101 may stop the growth of cancer
      cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to
      the cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Biopsy-proven (no needle aspirations or cytologies) aggressive B-cell non-Hodgkin's
             lymphoma (NHL), including 1 of the following histology subtypes:

               -  Diffuse large cell NHL

               -  Burkitt's or Burkitt-like NHL

               -  Primary mediastinal NHL

          -  Relapsed or refractory disease

          -  Bidimensionally measurable disease

          -  Transformed NHL allowed

          -  Not eligible for stem cell transplantation (for patients registered to study at first
             relapse)

          -  No active CNS involvement by lymphoma

          -  Zubrod performance status 0-2

          -  No history of allergic reactions attributed to compounds of similar chemical or
             biologic composition to PXD101

          -  Absolute neutrophil count >= 1,500/mm^3

          -  Platelet count>=100,000/mm^3

          -  WBC >= 3,000/mm^3

          -  Creatinine < 2 times upper limit of normal (ULN) OR creatinine clearance >= 60 mL/min

          -  No significant EKG abnormalities

          -  Bilirubin normal

          -  SGOT/SGPT < 2.5 times ULN (=< 5 times ULN if liver involvement)

          -  No long QT syndrome or marked baseline prolongation of QT/QTc interval (e.g., repeated
             demonstration of QTc interval > 500 msec)

          -  No other significant cardiovascular disease, including any of the following:

               -  Unstable angina pectoris

               -  Uncontrolled hypertension

               -  Congestive heart failure related to primary cardiac disease

               -  Any condition requiring anti-arrhythmic therapy

               -  Ischemic or severe valvular heart disease

               -  Myocardial infarction within the past 6 months

          -  No major surgery within 28 days prior to study entry

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  No concurrent medication that may cause Torsades de Pointes (i.e., prolongation of the
             QT interval > 500 msec)

          -  At least 14 days since prior radiotherapy

          -  At least 2 weeks since prior valproic acid or any other histone deacetylase inhibitor

          -  No clinical evidence of any of the following:

               -  Severe peripheral vascular disease

               -  Diabetic ulcers or venous stasis ulcers

               -  History of deep venous or arterial thrombosis within the past 3 months

          -  Radioimmunotherapy is considered a chemotherapy regimen

          -  Single-agent rituximab is not considered a chemotherapy regimen

          -  Standard salvage chemotherapy followed by autologous stem cell transplantation is
             considered 1 regimen

          -  No known AIDS or HIV-associated complex

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer or in situ carcinoma of the cervix

          -  At least 2 weeks since prior therapy and recovered

          -  No more than 5 prior chemotherapy regimens