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

Completed · Phase 2

Conditions studied: Anaplastic Large Cell Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Mantle Cell Lymphoma

In brief

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

Key facts

Study ID

NCT00278382

Run by

National Cancer Institute (NCI)

People needed

33

Starts

2005-10-01

Last updated by the study team

2013-02-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• University of Maryland Greenebaum Cancer Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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