Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
Bevacizumab (rhuMab VEGF) (NSC-704865) Therapy for Patients With Relapsed Aggressive Non-Hodgkin's Lymphoma
Phase II trial to study the effectiveness of bevacizumab in treating patients who have non-Hodgkin's lymphoma. Monoclonal antibodies such as bevacizumab may stop the growth of cancer by stopping blood flow to the tumor. Bevacizumab may be an effective treatment for non-Hodgkin's lymphoma
PRIMARY OBJECTIVES:
I. To estimate the 6-month progression-free survival rate in patients with relapsed
aggressive NHL treated with single agent bevacizumab therapy.
II. To evaluate response rate and toxicity in patients with relapsed aggressive NHL treated
with this regimen.
III. To measure tumor VEGF and VEGF receptor 1 and 2 expression (Flt-1 and Flk-1/KDR) and to
explore the correlation between expression level and histology and response.
IV. To measure pre-therapy, week 8 and time to progression biologic measures of VEGF
activity including plasma VEGF levels, urinary VEGF levels, and circulating number of
endothelial cells and explore the correlation with response.
OUTLINE:
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every
28 days for a maximum of 24 courses in the absence of disease progression or unacceptable
toxicity.
Patients are followed every 6 months for 3 years
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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