A Phase II Trial of SU5416 (NSC #696819) in Patients With Metastatic Melanoma
I. Determine the objective response rate and stabilization of disease rates of patients with
previously treated metastatic melanoma treated with SU5416.
II. Determine the toxicity of SU5416 in this patient population. III. Determine the median
and overall survival and time to progression in these patients receiving this treatment.
OUTLINE: This is a multicenter study.
Patients receive SU5416 IV over 60 minutes twice weekly for 4 weeks. Treatment continues for
a minimum of 2 courses in the absence of unacceptable toxicity or disease progression.
Patients are followed weekly for 4 weeks.
PROJECTED ACCRUAL: A total of 14-35 patients will be accrued for this study within 18-24
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete response rate
Up to 3 years
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
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