A Phase II Study Of Epothilone B Analog BMS-247550 (NSC 710428) In Patients With Relapsed Aggressive Non-Hodgkin's Lymphomas
I. Determine the objective overall response rate of patients with relapsed or refractory
aggressive non-Hodgkin's lymphoma treated with BMS-247550 (ixabepilone).
II. Determine the safety and toxicity of this drug in these patients. III. Determine the
duration of response, overall survival, and time to progression in patients treated with
OUTLINE: This is a multi-center study.
Patients receive ixabepilone intravenously (IV) over 1 hour on days 1, 8, and 15. Courses
repeat every 28 days in the absence of disease progression, unacceptable toxicity, or if the
patient becomes a candidate for stem cell transplantation.
Patients are followed every 8 weeks until disease progression.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective overall response rate to intravenous administration of ixabepilone in patients with relapsed chemosensitive or refractory aggressive NHL
Each patient will be assigned one of the following categories: 1) complete response or CRu, 2) partial response, 3) stable disease, 4) progressive disease, 5) early death from malignant disease, 6) early death from toxicity, 7) early death because of other cause, or 9) unknown (not assessable, insufficient data). The 95% confidence intervals will be provided.
Every 8 weeks and then 4 weeks following initial objective response
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
|University of Chicago Comprehensive Cancer Center||Chicago, Illinois 60637-1470|
|M D Anderson Cancer Center||Houston, Texas 77030|