NCT00006014

SU5416 in Treating Patients With Malignant Mesothelioma

A Phase II Trial of SU5416 (NSC# 696819) in Patients With Malignant Mesothelioma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (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 SU5416 in treating patients who have malignant mesothelioma. SU5416 may stop the growth of malignant mesothelioma by stopping blood flow to the tumor.

Detailed description

OBJECTIVES: 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 months.

Conditions

• Malignant Mesothelioma

Interventions

Type	Name	Description
DRUG	semaxanib

Timeline

• Start date: 2000-08-01
• Primary completion: 2007-02-01
• Completion: 2009-02-01
• First posted: 2004-02-26
• Last updated: 2013-06-03

Locations

10 sites across 1 country: United States