Sorafenib Tosylate in Treating Patients With Recurrent Aggressive Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Niacinamide; Sorafenib

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