SU5416 may stop the growth of malignant melanoma by stopping blood flow to the tumor. Phase II trial to study the effectiveness of SU5416 in treating patients who have metastatic melanoma that has been previously treated
PRIMARY OBJECTIVES: 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 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Given IV
Correlative studies
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Complete response rate
Time frame: Up to 3 years
Overall response rate (complete and partial responses)
Time frame: Up to 3 years
Maintenance of stable disease
Time frame: Up to 3 years
Treatment toxicity
Time frame: Up to 4 weeks post treatment
Time to progression
Kaplan-Meier estimates will be calculated.
Time frame: Up to 3 years
Survival
Kaplan-Meier estimates will be calculated.
Time frame: Up to 3 years
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