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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00131937
First received: August 16, 2005
Last updated: April 9, 2013
Last verified: April 2013

August 16, 2005
April 9, 2013
October 2005
November 2007   (final data collection date for primary outcome measure)
  • Response rate based on the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin's Lymphoma [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Toxicity rates graded according to the Common Terminology Criteria for Adverse Events version 3.0 [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00131937 on ClinicalTrials.gov Archive Site
  • Duration of response [ Time Frame: From the documented beginning of response (CR, CRu or PR) to the time of relapse, assessed up to 3 years ] [ Designated as safety issue: No ]
    Estimated using the Kaplan-Meier method.
  • Progression-free survival [ Time Frame: From randomization to the first of progression, relapse, or death from any cause, assessed up to 3 years ] [ Designated as safety issue: No ]
    Estimated using the Kaplan-Meier method.
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Sorafenib Tosylate in Treating Patients With Recurrent Aggressive Non-Hodgkin's Lymphoma
A Phase II Study of Sorafenib (BAY 43-9006) in 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.

PRIMARY OBJECTIVES:

I. To evaluate the response rate of treatment with sorafenib (BAY43-9006) in patients with recurrent aggressive non-Hodgkin's lymphomas.

SECONDARY OBJECTIVES:

I. To evaluate the duration of response and progression free survival of treatment with BAY43-9006 in patients with recurrent aggressive Non-Hodgkin's Lymphomas.

II. To characterize the toxicity of treatment with BAY43-9006 in patients with recurrent aggressive Non-Hodgkin's Lymphomas.

III. To further characterize the pharmacokinetics properties of BAY43-9006 and assess influence of monooxygenases polymorphisms and MDR on pharmacokinetics.

OUTLINE: This is a multicenter study.

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 1 year.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Anaplastic Large Cell Lymphoma
  • Angioimmunoblastic T-cell Lymphoma
  • Hepatosplenic T-cell Lymphoma
  • Peripheral T-cell Lymphoma
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Adult Immunoblastic Large Cell Lymphoma
  • Recurrent Adult T-cell Leukemia/Lymphoma
  • Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Drug: sorafenib tosylate
Given orally
Other Names:
  • BAY 43-9006
  • BAY 43-9006 Tosylate Salt
  • BAY 54-9085
  • Nexavar
  • SFN
Experimental: Treatment (sorafenib tosylate)
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention: Drug: sorafenib tosylate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
Not Provided
November 2007   (final data collection date for primary outcome measure)

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)
  • Patients must have no CNS involvement
  • 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 not have been previously treated with Sorafenib (BAY 43-9006) or other small molecule targeted inhibitors of MAPK signaling intermediates or angiogenesis (e.g. bevacizumab,/Avastin, oral MEK inhibitor CI-1040)
  • Patients must have failed one or more prior NHL chemotherapy or antibody therapy with curative intent; autologous stem cell transplant is permitted
  • Patients must not have progressed within 60 days of last therapy
  • Patients must not have received prior allogeneic stem cell transplant
  • Patients must not be candidates for potentially curative therapy, such as HSCT, OR must have refused these alternative therapies
  • Patients must not be receiving any other investigational agents
  • Patients must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib
  • Patients must not have 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
  • 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
  • AST =< 2.5 X institutional upper limit of normal
  • 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
  • PT/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 not have active HIV infection, because of possible pharmacokinetic interactions of anti-retroviral therapy with BAY43-9006
  • Patients must be physically able to orally ingest tablets
  • Patients must not have any evidence of bleeding diathesis
  • Patients must not be taking the cytochrome P450 enzyme-inducing anti-epileptic drugs (phenytoin, carbamazepine and phenobarbital), rifampin or St. John's Wort
  • Women must not be pregnant or breast-feeding because the side effects of BAY43-9006 on developing embryos and nursing infants are unknown; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy

Exclusion Criteria:

  • Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00131937
NCI-2012-02955, E1404, ECOG-E1404, U10CA021115
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Sandra Horning Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP