VEGF Trap in Treating Patients With Relapsed or Refractory Solid Tumors or Non-Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT00036946|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 3, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma Unspecified Adult Solid Tumor, Protocol Specific||Biological: ziv-aflibercept||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||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|
|Study Start Date :||November 2001|
|Actual Primary Completion Date :||March 2002|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00036946
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Jakob Dupont, MD||Memorial Sloan Kettering Cancer Center|