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: NCT00082823|
Recruitment Status : Completed
First Posted : May 19, 2004
Last Update Posted : June 3, 2016
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.
|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 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Long-Term, Safety and Tolerability 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): NCT00082823
|United States, New York|
|Memorial Sloan - Kettering Cancer Center|
|New York, New York, United States, 10021|
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|Principal Investigator:||William P. Tew, MD||Memorial Sloan Kettering Cancer Center|