Working... Menu
Trial record 65 of 877 for:    "Reticulum Cell Sarcoma"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00278382
Recruitment Status : Completed
First Posted : January 18, 2006
Last Update Posted : February 7, 2013
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
Sorafenib may stop the growth of cancer cells by blocking blood flow to the cancer and by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well sorafenib works in treating patients with chemosensitive recurrent aggressive non-Hodgkin's lymphoma

Condition or disease Intervention/treatment Phase
Anaplastic Large Cell Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Mantle Cell Lymphoma Drug: sorafenib tosylate Other: laboratory biomarker analysis Phase 2

Detailed Description:


I. Determine the overall response rate, including complete and partial responses, in patients with chemosensitive, relapsed, aggressive, non-Hodgkin's lymphoma treated with sorafenib.


I. Determine progression-free and overall survival of patients treated with this drug.

II. Determine response duration in patients treated with this drug.

OUTLINE: This is an open-label study.

Patients receive oral sorafenib twice daily in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of BAY 43-9006 (IND 69896) in Chemosensitive Relapsed Aggressive Non-Hodgkin's Lymphomas
Study Start Date : October 2005
Actual Primary Completion Date : December 2007

Arm Intervention/treatment
Experimental: Treatment (sorafenib tosylate)
Patients receive oral sorafenib twice daily 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

Other: laboratory biomarker analysis
Correlative studies

Primary Outcome Measures :
  1. Objective response rate (complete and partial response) [ Time Frame: Up to 2 years ]
    Will be calculated as the percent of evaluable patients whose best response is a CR or PR. The exact binomial method will be used to determine the confidence interval of response rate.

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Up to 2 years ]
    The Kaplan-Meier product-limit method will be used in analysis of survival time.

  2. Time to disease progression [ Time Frame: Up to 2 years ]
    The Kaplan-Meier product-limit method will be used in analysis of time to disease progression.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically confirmed aggressive* non-Hodgkin's lymphoma by excisional-node biopsy or core needle biopsy and bone marrow biopsy, including 1 of the following types:

    • Mantle cell lymphoma
    • Primary mediastinal large B-cell lymphoma
    • Diffuse large B-cell lymphoma
    • Anaplastic large cell lymphoma (T-cell or null-cell type)
  • Recurrent disease
  • Patients must have received ≥ 1 induction regimen containing anthracyclines (e.g., CHOP [with or without rituximab] or R-EPOCH)
  • Chemosensitive disease at the time of relapse

    • Patients who responded with a complete or partial remission that lasted at least 8 weeks after their last chemotherapy regimen are considered chemosensitive
  • Measurable disease, defined as a lymph node or a nodal mass of > 1 cm in its longest transverse diameter on CT scan
  • Ineligible for, refused, or relapsed after stem cell transplant (for patients with non-mantle cell lymphoma)
  • No known brain metastases, including meningeal involvement
  • ECOG performance status (PS) 0-2
  • Karnofsky PS 60-100%
  • Life expectancy > 3 months
  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Bilirubin normal
  • AST and ALT ≤ 2.5 times upper limit of normal
  • Creatinine normal OR creatinine clearance ≥ 60 mL/min
  • Fertile patients must use effective contraception
  • Not pregnant or nursing
  • Negative pregnancy test
  • No uncontrolled illness
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib
  • No known positive HIV serology
  • No inflammatory bowel disease
  • No swallowing dysfunction that would prevent ingestion of pills
  • No hemorrhagic diathesis
  • No ongoing or active infection
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No uncontrolled hypertension
  • No psychiatric or social situation that would limit compliance with study requirements
  • No poorly controlled medical condition that would seriously complicate compliance with this study
  • Patients with inflammatory or exfoliative skin disease are excluded (regardless of the extent of the involvement) unless the skin condition is lymphoma related
  • See Disease Characteristics
  • Previous treatment-related toxic effects should be resolved to grade 1 or better
  • No chemotherapy or radiation therapy within the past 4 weeks

    • 6 weeks for nitrosoureas or mitomycin C
  • No prior antibody therapy for at least 3 months
  • Prior radiation for localized disease or total body irradiation as part of a conditioning regimen prior to stem cell transplant allowed
  • Prior radio-immunotherapy allowed
  • No concurrent therapeutic anticoagulation

    • Prophylactic anticoagulation (i.e., low-dose warfarin) of venous or arterial access devices are acceptable provided that the requirements for PT, INR, and PTT are met
  • No concurrent use of another investigational agent
  • No concurrent use of the following drugs: phenytoin, carbamazepine, phenobarbital, rifampin, or Hypericum perforatum (St. John's wort)
  • No other concurrent anticancer therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00278382

Layout table for location information
United States, Maryland
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201-1595
Sponsors and Collaborators
National Cancer Institute (NCI)
Layout table for investigator information
Principal Investigator: Meyer Heyman University of Maryland Greenebaum Cancer Center

Layout table for additonal information
Responsible Party: National Cancer Institute (NCI) Identifier: NCT00278382     History of Changes
Other Study ID Numbers: NCI-2012-02682
CDR0000456442 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 18, 2006    Key Record Dates
Last Update Posted: February 7, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma, Non-Hodgkin
Lymphoma, Mantle-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Large-Cell, Anaplastic
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, T-Cell
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action