NCT00017316

Thalidomide and SU5416 in Treating Patients With Metastatic Melanoma

A Phase II, Pharmacologic and Biologic Study of Escalating Doses of Thalidomide (NSC #66847) Administered Orally Once a Day in Combination With a Fixed Dose of SU5416 (NSC #696819) in Patients With Metastatic Melanoma

• Status: Completed
• 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

Phase II trial to study the effectiveness of combining thalidomide and SU5416 in treating patients who have metastatic melanoma. Thalidomide combined with SU5416 may stop the growth of metastatic melanoma by stopping blood flow to the tumor.

Detailed description

OBJECTIVES: I. Determine the efficacy of thalidomide and SU5416 in patients with metastatic melanoma. II. Determine the quantitative and qualitative toxic effects of this regimen in these patients. III. Evaluate the pharmacokinetics of this regimen in these patients. IV. Determine the complete and partial responses and response duration in patients treated with this regimen. V. Assess disease-free survival at 6 months of patients treated with this regimen. OUTLINE: Patients receive SU5416 IV over 1 hour twice weekly and oral thalidomide daily beginning 1 day after the first dose of SU5416. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
DRUG	semaxanib
DRUG	thalidomide

Timeline

• Start date: 2001-03-01
• Primary completion: 2003-09-01
• First posted: 2003-06-12
• Last updated: 2013-02-11

Locations

1 site across 1 country: United States