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
  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.


Condition Intervention Phase
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
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Sorafenib (BAY 43-9006) in Recurrent Aggressive Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 41
Study Start Date: October 2005
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: sorafenib tosylate
Given orally
Other Names:
  • BAY 43-9006
  • BAY 43-9006 Tosylate Salt
  • BAY 54-9085
  • Nexavar
  • SFN

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131937

Locations
United States, Massachusetts
Eastern Cooperative Oncology Group
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Investigators
Principal Investigator: Sandra Horning Eastern Cooperative Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00131937     History of Changes
Other Study ID Numbers: NCI-2012-02955, E1404, ECOG-E1404, U10CA021115
Study First Received: August 16, 2005
Last Updated: April 9, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Immunoblastic Lymphadenopathy
Leukemia
Leukemia, T-Cell
Leukemia-Lymphoma, Adult T-Cell
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Large-Cell, Immunoblastic
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell, Peripheral
Lymphoma, Large-Cell, Anaplastic
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Histologic Type
Neoplasms
Leukemia, Lymphoid
Lymphoma, B-Cell
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014