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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00082823
Recruitment Status : Completed
First Posted : May 19, 2004
Last Update Posted : June 3, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

May 14, 2004
May 19, 2004
June 3, 2016
January 2004
May 2008   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00082823 on Archive Site
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Intravenous VEGF Trap in Treating Patients With Relapsed or Refractory Advanced Solid Tumors or Non-Hodgkin's Lymphoma
An Open-Label, Long-Term, Safety and Tolerability Study of VEGF Trap Administered Intravenously in Patients With Advanced Solid Tumors or Lymphoma

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.



  • 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.

Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Biological: ziv-aflibercept
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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May 2008   (Final data collection date for primary outcome measure)


  • Histologically confirmed non-Hodgkin's lymphoma OR primary or metastatic solid tumor located in at least one of the following sites:

    • Liver
    • Soft tissue
    • Pelvis
    • Other site that is suitable for delayed contrast-enhancing MRI
  • Relapsed or refractory disease

    • Failed all conventional therapeutic options AND not amenable to existing therapeutic options
  • Must have completed the active phase (through study visit 9) of MSKCC-03137 (VGFT-ST-0202) without experiencing dose-limiting toxicity
  • No prior or concurrent CNS metastases (brain or leptomeningeal)

    • No new neurological symptoms during treatment on MSKCC-03137 (VGFT-ST-0202)



  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified


  • No severe or uncontrolled hematologic condition


  • Not specified


  • No severe or uncontrolled renal condition


  • No severe or uncontrolled cardiovascular condition


  • No severe or uncontrolled pulmonary condition


  • No severe or uncontrolled gastrointestinal, immunologic, or musculoskeletal condition
  • No other medical or psychiatric condition or adverse social circumstance that would preclude study participation
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective double-barrier contraception during and for 3 months after study treatment


Biologic therapy

  • No concurrent epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF)


  • Not specified

Endocrine therapy

  • No concurrent adrenal corticosteroids, except low-dose replacement therapy
  • No concurrent systemic hormonal contraceptive agents


  • Not specified


  • Not specified


  • No concurrent non-steroidal anti-inflammatory drugs, including cyclo-oxygenase-2 (COX-2) inhibitors
  • No concurrent anticoagulant or antiplatelet drugs, including warfarin, heparin, or aspirin

    • Concurrent low-dose (i.e., 1 mg) warfarin for maintaining patency of venous access devices allowed
  • No other concurrent standard or investigational agents for this malignancy
Sexes Eligible for Study: All
18 Years to 120 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000360846 ( Registry Identifier: PDQ (Physician Data Query) )
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Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
National Cancer Institute (NCI)
Principal Investigator: William P. Tew, MD Memorial Sloan Kettering Cancer Center
Regeneron Pharmaceuticals
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP