Sorafenib in Treating Patients With Recurrent Non-Hodgkin's Lymphoma
- Conditions
- Anaplastic Large Cell LymphomaRecurrent Mantle Cell LymphomaRecurrent Adult Diffuse Large Cell Lymphoma
- Interventions
- Other: laboratory biomarker analysis
- Registration Number
- NCT00278382
- Lead Sponsor
- 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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
-
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
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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)
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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
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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
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No concurrent use of another investigational agent
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No concurrent use of the following drugs: phenytoin, carbamazepine, phenobarbital, rifampin, or Hypericum perforatum (St. John's wort)
-
No other concurrent anticancer therapy
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment (sorafenib tosylate) sorafenib tosylate Patients receive oral sorafenib twice daily in the absence of disease progression or unacceptable toxicity. Treatment (sorafenib tosylate) laboratory biomarker analysis Patients receive oral sorafenib twice daily in the absence of disease progression or unacceptable toxicity.
- Primary Outcome Measures
Name Time Method Objective response rate (complete and partial response) 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
Name Time Method Overall survival Up to 2 years The Kaplan-Meier product-limit method will be used in analysis of survival time.
Time to disease progression Up to 2 years The Kaplan-Meier product-limit method will be used in analysis of time to disease progression.
Trial Locations
- Locations (1)
University of Maryland Greenebaum Cancer Center
🇺🇸Baltimore, Maryland, United States