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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00278382
First received: January 16, 2006
Last updated: February 6, 2013
Last verified: February 2013
  Purpose

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 Intervention Phase
Anaplastic Large Cell Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Mantle Cell Lymphoma
Drug: sorafenib tosylate
Other: laboratory biomarker analysis
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 2 Study of BAY 43-9006 (IND 69896) in Chemosensitive Relapsed Aggressive Non-Hodgkin's Lymphomas

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Objective response rate (complete and partial response) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    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:
  • Overall survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    The Kaplan-Meier product-limit method will be used in analysis of survival time.

  • Time to disease progression [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    The Kaplan-Meier product-limit method will be used in analysis of time to disease progression.


Enrollment: 33
Study Start Date: October 2005
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

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.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00278382

Locations
United States, Maryland
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201-1595
Sponsors and Collaborators
Investigators
Principal Investigator: Meyer Heyman University of Maryland Greenebaum Cancer Center
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00278382     History of Changes
Other Study ID Numbers: NCI-2012-02682, GCC0508, CDR0000456442
Study First Received: January 16, 2006
Last Updated: February 6, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014