NCT00450255

VEGF Trap in Treating Patients With Recurrent Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery

A Phase 2 Study Evaluating the Efficacy of VEGF Trap in Patients With Recurrent Inoperable Stage III or Stage IV Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well VEGF Trap works in treating patients with recurrent stage III or stage IV melanoma that cannot be removed by surgery. Combinations of biological substances in VEGF Trap may be able to carry tumor-killing substances directly to melanoma cells. It may also stop the growth of melanoma by blocking blood flow to the tumor.

Detailed description

PRIMARY OBJECTIVES: I. Determine the antitumor response rate (complete and partial response) in patients with recurrent inoperable stage III or IV melanoma treated with VEGF Trap. II. Compare the progression-free survival of patients treated with this regimen vs historical controls. SECONDARY OBJECTIVES: I. Determine the overall survival of patients treated with this regimen. II. Determine the toxicity and tolerability of this regimen in these patients. III. Determine the impact of this regimen on laboratory correlates including anti-VEGF Trap antibody testing and pharmacokinetics in these patients. OUTLINE: This is a multicenter study. Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline, prior to course 2, and 60 days after completion of study treatment for pharmacokinetic and pharmacodynamic studies. Samples are analyzed by enzyme-linked immunosorbent assay. After completion of study treatment, patients are followed periodically for 5 years.

Conditions

• Ciliary Body and Choroid Melanoma, Medium/Large Size
• Extraocular Extension Melanoma
• Iris Melanoma
• Metastatic Intraocular Melanoma
• Recurrent Intraocular Melanoma
• Recurrent Melanoma
• Stage III Melanoma
• Stage IV Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	ziv-aflibercept	Given IV
OTHER	pharmacological study	Correlative studies

Timeline

• Start date: 2007-06-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2007-03-22
• Last updated: 2018-05-24
• Results posted: 2015-02-04

Locations

1 site across 1 country: United States