Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Drug: sorafenib tosylate

Phase:

Phase 2

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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sarah Daadi
6507256456
Not Recruiting