Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Sorafenib in Treating Patients With Recurrent Diffuse Large B-Cell Non-Hodgkin's Lymphoma
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00131937
  Purpose

RATIONALE: 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.

PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with recurrent diffuse large B-cell non-Hodgkin's lymphoma.


Condition Intervention Phase
Lymphoma
Drug: sorafenib tosylate
Phase II

MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Sorafenib Sorafenib tosylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of Sorafenib (BAY 43-9006) in Recurrent Aggressive Non-Hodgkin's Lymphoma

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

Primary Outcome Measures:
  • Tumor response rate by Chesen criteria at 2 and 6 months during treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of response at time of progression [ Designated as safety issue: No ]
  • Progression-free survival at time of progression [ Designated as safety issue: No ]
  • Toxicity at time of progression [ Designated as safety issue: Yes ]
  • Pharmacokinetics at time of progression [ Designated as safety issue: No ]

Estimated Enrollment: 41
Study Start Date: October 2005
Detailed Description:

OBJECTIVES:

Primary

  • Determine the response rate in patients with recurrent de novo or transformed diffuse large B-cell non-Hodgkin's lymphoma treated with sorafenib.

Secondary

  • Determine the duration of response and progression-free survival of patients treated with this drug.
  • Determine the toxicity of this drug in these patients.
  • Determine the pharmacokinetics of this drug in these patients.

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.

PROJECTED ACCRUAL: A total of 13-41 patients will be accrued for this study within 4-14 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed de novo or transformed diffuse large B-cell non-Hodgkin's lymphoma (NHL) OR one of the following variants, according to the WHO classification system

    • Centroblastic
    • Immunoblastic
    • T-cell/histiocyte rich
    • Anaplastic
  • Recurrent disease

    • Must have failed ≥ 1 prior chemotherapy or antibody therapy regimen for NHL with curative intent

      • No disease progression within 60 days of last therapy
  • Measurable disease
  • No CNS involvement
  • Ineligible for or refused potentially curative therapy (e.g., hematopoietic stem cell transplantation or other alternative therapy)

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • WBC ≥ 2,000/mm^3*
  • Absolute neutrophil count ≥ 1,000/mm^3*
  • Platelet count ≥ 75,000/mm^3*
  • No bleeding diathesis NOTE: *Unless related to lymphoma activity

Hepatic

  • PT/INR normal
  • Bilirubin ≤ 2.0 times normal*
  • AST and ALT ≤ 2.5 times upper limit of normal* NOTE: *Unless related to lymphoma activity

Renal

  • Creatinine normal* OR
  • Creatinine clearance ≥ 60 mL/min* NOTE: *Unless related to lymphoma activity

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No underlying hypertension (i.e., blood pressure averaging ≥ 140/90 mm Hg on 2 separate clinic visits) unless hypertension is controlled by standard nonpharmacologic or pharmacologic therapy

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able to ingest oral medication
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No history of allergic reaction attributed to compounds of similar chemical or biological composition to sorafenib
  • No other uncontrolled illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • Prior autologous stem cell transplantation allowed
  • No prior allogeneic stem cell transplantation
  • No other prior small molecule targeted angiogenesis inhibitors (e.g., bevacizumab or CI-1040)

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • No prior sorafenib
  • No other prior small molecule targeted inhibitors of MAPK signaling intermediates
  • No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs, including any of the following:

    • Phenytoin
    • Carbamazepine
    • Phenobarbital
  • No concurrent rifampin or Hypericum perforatum (St. John's wort)
  • No other concurrent investigational agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00131937

  Show 146 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Investigator: Sandra J. Horning, MD Stanford University
Study Chair: Daniel R. Greenwald, MD Stanford University
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000437860, ECOG-E1404
Study First Received: August 16, 2005
Last Updated: May 23, 2008
ClinicalTrials.gov Identifier: NCT00131937  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult diffuse large cell lymphoma

Study placed in the following topic categories:
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Lymphoma, small cleaved-cell, diffuse
Recurrence
Lymphoma, B-Cell
Lymphoma, large-cell
Lymphatic Diseases
B-cell lymphomas
Lymphoma, Non-Hodgkin
Aggression
Lymphoproliferative Disorders
Lymphoma
Sorafenib

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009