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

Primary Purpose

Anaplastic Large Cell Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Mantle Cell Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sorafenib tosylate
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anaplastic Large Cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Maryland Greenebaum Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (sorafenib tosylate)

Arm Description

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

Outcomes

Primary Outcome Measures

Objective response rate (complete and partial response)
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
The Kaplan-Meier product-limit method will be used in analysis of survival time.
Time to disease progression
The Kaplan-Meier product-limit method will be used in analysis of time to disease progression.

Full Information

First Posted
January 16, 2006
Last Updated
February 6, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00278382
Brief Title
Sorafenib in Treating Patients With Recurrent Non-Hodgkin's Lymphoma
Official Title
A Phase 2 Study of BAY 43-9006 (IND 69896) in Chemosensitive Relapsed Aggressive Non-Hodgkin's Lymphomas
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anaplastic Large Cell Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Mantle Cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (sorafenib tosylate)
Arm Type
Experimental
Arm Description
Patients receive oral sorafenib twice daily in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
sorafenib tosylate
Other Intervention Name(s)
BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar, SFN
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Objective response rate (complete and partial response)
Description
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.
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
The Kaplan-Meier product-limit method will be used in analysis of survival time.
Time Frame
Up to 2 years
Title
Time to disease progression
Description
The Kaplan-Meier product-limit method will be used in analysis of time to disease progression.
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meyer Heyman
Organizational Affiliation
University of Maryland Greenebaum Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201-1595
Country
United States

12. IPD Sharing Statement

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

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