Spots Global Cancer Trial Database for Intravenous VEGF Trap in Treating Patients With Relapsed or Refractory Advanced Solid Tumors or Non-Hodgkin's Lymphoma

Study Description

Brief Summary: RATIONALE: VEGF Trap may stop the growth of solid tumors or non-Hodgkin's lymphoma by stopping blood flow to the tumor. PURPOSE: This phase I trial is studying the side effects and best dose of intravenous 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 maximum tolerated intravenous dose of this drug in these patients. * Determine the pharmacokinetics of this drug in these patients. * Determine the ability of this drug to bind circulating vascular endothelial growth factor in these patients. * Determine, preliminarily, the ability of this drug to alter tumor blood flow and tumor vascular permeability in these patients. * Determine whether antibodies to this drug develop in these patients. OUTLINE: This is an open-label, dose-escalation, multicenter study. Patients receive VEGF Trap IV over 1 hour on days 1 and 15 for a total of 2 doses. Cohorts of 3-6 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, an additional 6 patients are treated at that dose level. In the absence of dose-limiting toxicity, patients with stable disease or partial or complete remission may continue to receive VEGF Trap on a separate extension protocol. Patients are followed at weeks 1, 3, and 7 and then at 3 months. PROJECTED ACCRUAL: A maximum of 25 patients will be accrued for this study.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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