NCT00082823

Intravenous VEGF Trap in Treating Patients With Relapsed or Refractory Advanced Solid Tumors or Non-Hodgkin's Lymphoma

An Open-Label, Long-Term, Safety and Tolerability Study of VEGF Trap Administered Intravenously in Patients With Advanced Solid Tumors or Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Intravenous VEGF Trap may stop the growth of solid tumors or non-Hodgkin's lymphoma by stopping blood flow to the cancer. PURPOSE: This phase I trial is studying the side effects of VEGF Trap in treating patients with relapsed or refractory advanced solid tumors or non-Hodgkin's lymphoma.

Detailed description

OBJECTIVES: Primary * Determine the safety and tolerability of intravenous VEGF Trap in patients with relapsed or refractory advanced solid tumors or non-Hodgkin's lymphoma. Secondary * Determine the steady-state pharmacokinetics of this drug in these patients. * Determine the ability of this drug to bind circulating vascular endothelial growth factor in these patients. * Determine whether antibodies to this drug develop in these patients. * Determine, preliminarily, the ability of repeated doses of this drug to alter tumor growth and vascular permeability in these patients. OUTLINE: This is an open-label, multicenter, extension study. Patients receive VEGF Trap\* IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. NOTE: \*Patients receive the same drug dose that they received in MSKCC-03137 (VGFT-ST-0202) Patients are followed monthly for 3 months. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 3-6 months.

Conditions

• Cancer

Interventions

Type	Name	Description
BIOLOGICAL	ziv-aflibercept

Timeline

• Start date: 2004-01-01
• Primary completion: 2008-05-01
• First posted: 2004-05-19
• Last updated: 2016-06-03

Locations

2 sites across 1 country: United States