NCT00036946

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

An Open-Label, Sequential Cohort Dose-Escalation Safety, Tolerability And Pharmacokinetic Study Of VEGF Trap In Patients With Incurable, Relapsed Or Refractory Solid Tumors Or Lymphoma

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

Summary

RATIONALE: VEGF Trap may stop the growth of solid tumors or non-Hodgkin's lymphoma by stopping blood flow to the cancer. PURPOSE: Phase I trial to study the effectiveness of VEGF Trap in patients who have relapsed or refractory solid tumors or non-Hodgkin's lymphoma.

Detailed description

OBJECTIVES: * Determine the safety and tolerability of VEGF Trap in patients with incurable relapsed or refractory solid tumors or non-Hodgkin's lymphoma. * Determine the maximum tolerated dose of this drug in these patients. * Determine the pharmacokinetics of this drug in these patients. * Evaluate the ability of this drug to bind and inactivate circulating vascular endothelial growth factor (VEGF) in these patients. * Determine the dosing regimen that is optimal for neutralization of circulating VEGF in these patients. * Determine whether antibodies to this drug develop in these patients. * Assess, preliminarily, the ability of this drug to alter tumor vascular permeability and tumor growth in these patients. OUTLINE: This is a dose-escalation study. Patients receive VEGF Trap subcutaneously once daily on days 1, 29, 36, 43, 50, 57, and 64 in the absence of disease progression or unacceptable toxicity. Cohorts of 1-6 patients receive escalating doses of VEGF Trap until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 5 additional patients are treated at the MTD. Patients are followed at 1 and 4 weeks. PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.

Conditions

• Lymphoma
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
BIOLOGICAL	ziv-aflibercept

Timeline

• Start date: 2001-11-01
• Primary completion: 2002-03-01
• First posted: 2003-01-27
• Last updated: 2016-06-03

Locations

1 site across 1 country: United States