A Phase II Trial of SU5416 (NSC# 696819) in Patients With Malignant Mesothelioma
I. Determine the objective response rate, median and overall survival, and time to
progression in patients with unresectable malignant mesothelioma treated with SU5416.
II. Determine the effect of SU5416 on surrogate biologic endpoints, including microvessel
density, tissue proliferative index, apoptosis, vascular endothelial growth factor levels,
and tumor perfusion measured by MRI in these patients.
III. Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive SU5416 IV over 1 hour twice weekly. Courses repeat every 4 weeks for a
minimum of 2 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: Approximately 21-45 patients will be accrued for this study within 18-24
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Hedy L. Kindler, MD
University of Chicago
United States: Food and Drug Administration
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Evanston Northwestern Health Care||Evanston, Illinois 60201|
|Louis A. Weiss Memorial Hospital||Chicago, Illinois 60640|
|University of Illinois at Chicago||Chicago, Illinois 60612|
|Cancer Care Specialists of Central Illinois, S.C.||Decatur, Illinois 62526|
|Oncology/Hematology Associates of Central Illinois, P.C.||Peoria, Illinois 61602|
|Central Illinois Hematology Oncology Center||Springfield, Illinois 62701|
|Fort Wayne Medical Oncology and Hematology, Inc.||Fort Wayne, Indiana 46885-5099|
|Michiana Hematology/Oncology P.C.||South Bend, Indiana 46617|
|Division of Hematology/Oncology||Park Ridge, Illinois 60068|