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

Not Recruiting

Trial ID: NCT00131937

Purpose

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.

Official Title

A Phase II Study of Sorafenib (BAY 43-9006) in Recurrent Aggressive Non-Hodgkin's Lymphoma

Stanford Investigator(s)

Harlan Pinto
Harlan Pinto

Associate Professor of Medicine (Oncology) and of Otolaryngology - Head & Neck Surgery

Eligibility

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

Intervention(s):

drug: sorafenib tosylate

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sarah Daadi
6507256456

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