Intravenous VEGF Trap in Treating Patients With Relapsed or Refractory Advanced Solid Tumors or Non-Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT00083213|
Recruitment Status : Completed
First Posted : May 19, 2004
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 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.
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Biological: ziv-aflibercept||Phase 1|
- Determine the safety and tolerability of intravenous VEGF Trap in patients with relapsed or refractory advanced solid tumors or non-Hodgkin's lymphoma.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, Sequential Cohort Dose-Escalation Safety, Tolerability and Pharmacokinetic Study of VEGF Trap Administered Intravenously in Patients With Advanced Solid Tumors or Lymphoma|
|Study Start Date :||January 2004|
|Actual Primary Completion Date :||May 2008|
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): NCT00083213
|United States, New York|
|Memorial Sloan - Kettering Cancer Center|
|New York, New York, United States, 10021|
|Principal Investigator:||William P. Tew, MD||Memorial Sloan Kettering Cancer Center|