Sorafenib Tosylate in Treating Patients With Recurrent Aggressive Non-Hodgkin's Lymphoma
Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Hepatosplenic T-cell Lymphoma
About this trial
This is an interventional treatment trial for Anaplastic Large Cell Lymphoma
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
Sites / Locations
- Eastern Cooperative Oncology Group
Arms of the Study
Arm 1
Experimental
Treatment (sorafenib tosylate)
Patients receive oral sorafenib 400 mg PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.