Recurrent Adult Diffuse Large Cell Lymphoma Clinical Trial
Official title:
A Phase II Study of Sorafenib (BAY 43-9006) in Recurrent Aggressive Non-Hodgkin's Lymphoma
This phase II trial is studying how well sorafenib works in treating patients with recurrent diffuse large B-cell non-Hodgkin's lymphoma. Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PRIMARY OBJECTIVES:
I. To evaluate the response rate of treatment with sorafenib (BAY43-9006) in patients with
recurrent aggressive non-Hodgkin's lymphomas.
SECONDARY OBJECTIVES:
I. To evaluate the duration of response and progression free survival of treatment with
BAY43-9006 in patients with recurrent aggressive Non-Hodgkin's Lymphomas.
II. To characterize the toxicity of treatment with BAY43-9006 in patients with recurrent
aggressive Non-Hodgkin's Lymphomas.
III. To further characterize the pharmacokinetics properties of BAY43-9006 and assess
influence of monooxygenases polymorphisms and multi-drug resistance transporter (MDR) on
pharmacokinetics.
OUTLINE: This is a multicenter study.
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 1 year.
PLANNED ACCRUAL: 41 ACTUAL ACCRUAL: 14
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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