Sorafenib Tosylate in Treating Patients With Recurrent Aggressive Non-Hodgkin's Lymphoma
Condition: Anaplastic Large Cell Lymphoma; Angioimmunoblastic T-cell Lymphoma; Hepatosplenic T-cell Lymphoma; Peripheral T-cell Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Immunoblastic Large Cell Lymphoma; Recurrent Adult T-cell Leukemia/Lymphoma; Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Large-Cell, Immunoblastic; Plasmablastic Lymphoma; Leukemia, T-Cell; Lymphoma, T-Cell, Cutaneous; Leukemia-Lymphoma, Adult T-Cell; Lymphoma, Large-Cell, Anaplastic; Immunoblastic Lymphadenopathy; Recurrence
Intervention: sorafenib tosylate
Intervention description: Given orally
Intervention MeSH terms: Sorafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well sorafenib works in treating patients with recurrent
      diffuse large B-cell non-Hodgkin's lymphoma. Sorafenib may stop the growth of cancer cells by
      blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically confirmed recurrent de novo or transformed diffuse
             large B cell lymphoma (DLBCL) or one of its variants according to WHO classification
             (centroblastic, immunoblastic, T-cell/histiocyte rich and anaplastic variants)

          -  Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1

          -  Patients must have measurable disease as defined in section 6 assessed within 4 weeks
             of registration

          -  Patients must have failed one or more prior Non-Hodgkin lymphoma (NHL) chemotherapy or
             antibody therapy with curative intent; autologous stem cell transplant is permitted

          -  Leukocytes >= 2,000/mm^3

          -  Absolute neutrophil count >= 1,000/mm^3

          -  Platelets >= 75,000/ mm^3

          -  Total bilirubin =< 2.0 X normal institutional limits

          -  Aspartate Aminotransferase (AST) =< 2.5 X institutional upper limit of normal

          -  Alanine Aminotransferase (ALT) =< 2.5 X institutional upper limit of normal

          -  Creatinine within normal institutional limits; creatinine clearance calculated or
             measured at >= 60 ml/min/1.73m^2 if creatinine level is above institutional limits

          -  The prothrombin time (PT)/international normalized ratio (INR) within Institutional
             limits of normal

          -  Patients with underlying hypertension as defined by blood pressures averaging greater
             than 140/90 on two separate clinic visits are eligible if hypertension has been
             controlled by standard nonpharmacologic and pharmacologic therapy

          -  Patients must be physically able to orally ingest tablets

        Exclusion Criteria:

          -  Central nervous system (CNS) involvement

          -  Previously treated with Sorafenib (BAY 43-9006) or other small molecule targeted
             inhibitors of mitogen-activated protein kinase (MAPK) signaling intermediates or
             angiogenesis (e.g. bevacizumab)

          -  Progressed within 60 days of last therapy

          -  Prior allogeneic stem cell transplant

          -  Candidates for potentially curative therapy, such as hematopoietic stem cell
             transplantation (HSCT)

          -  Currently receiving any other investigational agents

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to sorafenib

          -  Uncontrolled intercurrent illness including, but not limited to: ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Active HIV infection, because of possible pharmacokinetic interactions of
             anti-retroviral therapy with BAY43-9006

          -  Evidence of bleeding diathesis

          -  Currently taking the cytochrome P450 enzyme-inducing anti-epileptic drugs (phenytoin,
             carbamazepine and phenobarbital), rifampin or St. John's Wort

          -  Pregnant or Breast-feeding; all females of childbearing potential must have a blood
             test or urine study within 2 weeks prior to registration to rule out pregnancy. Women
             of childbearing potential and sexually active males must be strongly advised to use an
             accepted and effective method of contraception