Sorafenib in Treating Patients With Recurrent Non-Hodgkin's Lymphoma
Anaplastic Large Cell Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Mantle Cell Lymphoma
About this trial
This is an interventional treatment trial for Anaplastic Large Cell Lymphoma
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
Sites / Locations
- University of Maryland Greenebaum Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment (sorafenib tosylate)
Patients receive oral sorafenib twice daily in the absence of disease progression or unacceptable toxicity.