NCT00006003

SU5416 in Treating Patients With Metastatic Melanoma That Has Been Previously Treated

A Phase II Trial of SU5416 (NSC #696819) in Patients With Metastatic Melanoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Recurrent Melanoma
• Stage IV Melanoma

Interventions

Type	Name	Description
DRUG	semaxanib	Given IV
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2000-07-01
• Primary completion: 2003-07-01
• First posted: 2003-01-27
• Last updated: 2013-01-24

Locations

1 site across 1 country: United States