Sorafenib Tosylate in Treating Patients With Recurrent Aggressive Non-Hodgkin's Lymphoma
Trial ID or NCT#
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.
A Phase II Study of Sorafenib (BAY 43-9006) in Recurrent Aggressive Non-Hodgkin's Lymphoma
- - 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
- - 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
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