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VEGF Trap in Treating Patients With 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: NCT00045266
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 3, 2016
National Cancer Institute (NCI)
Information provided by:
Regeneron Pharmaceuticals

Brief Summary:

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 treating 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

Detailed Description:


  • Determine the long-term safety and tolerability of VEGF Trap in patients with incurable relapsed or refractory solid tumors or non-Hodgkin's lymphoma with stable or responding disease after receiving treatment on protocol MSKCC-01131.
  • Determine the biological effect of this therapy on suppressing tumor growth or progression in these patients.
  • Determine the steady state concentration of VEGF Trap over time in these patients.
  • Determine whether patients develop antibodies to this therapy during extended exposure.

OUTLINE: This is an extension study for patients who showed evidence of stable disease or complete or partial remission after completing treatment on protocol MSKCC-01131.

Patients continue to receive VEGF Trap subcutaneously once weekly for up to an additional 6 months in the absence of unacceptable toxicity. Patients receive treatment at the same dose level as on protocol MSKCC-01131.

Patients are followed at approximately 30 days.

PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Long Term, Safety, and Tolerability Study of VEGF Trap in Patients With Incurable, Relapsed or Refractory Solid Tumors or Lymphoma
Study Start Date : April 2002
Actual Primary Completion Date : February 2007

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed incurable relapsed or refractory solid tumor or non-Hodgkin's lymphoma that has been treated on MSKCC-01131
  • Must have completed participation in protocol MSKCC-01131 through visit 16 and have shown evidence of stable disease or complete or partial remission of tumor burden and no evidence of symptomatic deterioration

    • No adverse event or toxicity which resulted in discontinuation of participation in protocol MSKCC-01131
    • If a patient experienced dose-limiting toxicity, then the patient must have demonstrated the ability to tolerate the same dose or a lower dose prior to entry in this study
  • No known or suspected squamous cell carcinoma of the lung
  • No prior or concurrent new neurological symptoms or CNS (brain or leptomeningeal) metastases during protocol MSKCC-01131



  • 25 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified


  • WBC at least 3,500/mm3
  • Absolute neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3
  • Hemoglobin at least 9.0 g/dL
  • No severe or uncontrolled hematologic condition


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST and ALT no greater than 2 times ULN
  • Alkaline phosphatase no greater than 2 times ULN
  • PT, PTT, and INR normal


  • Creatinine no greater than ULN
  • No 1+ or greater proteinuria
  • No severe or uncontrolled renal condition


  • No severe or uncontrolled cardiovascular condition


  • No severe or uncontrolled pulmonary condition


  • No prior hypersensitivity reactions to any recombinant proteins (e.g., VEGF Trap)
  • No severe or uncontrolled gastrointestinal, immunological, or musculoskeletal condition
  • No severe or uncontrolled psychiatric condition or adverse social circumstance that would preclude study
  • No other condition that would preclude study
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective double-barrier contraception during and for at least 3 months after study


Biologic therapy

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


  • No concurrent standard chemotherapy

Endocrine therapy

  • No concurrent adrenal corticosteroids except low doses as replacement therapy in patients who have previously received suppressive doses or for adrenal insufficiency
  • No concurrent systemic hormonal contraceptive agents


  • No concurrent radiotherapy


  • Not specified


  • At least 30 days since prior investigational therapy other than VEGF Trap
  • No concurrent standard or other investigational anticancer agents
  • No concurrent herbal supplements ("nutraceuticals")
  • No concurrent anticoagulant or antiplatelet drugs (e.g., warfarin, heparin, aspirin, or other nonsteroidal anti-inflammatory drugs) except selective cyclo-oxygenase-2 (COX-2) inhibitors for analgesia
  • No concurrent COX-2 inhibitors for tumor treatment or prophylaxis

Information from the National Library of Medicine

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 identifier (NCT number): NCT00045266

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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Regeneron Pharmaceuticals
National Cancer Institute (NCI)
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Study Chair: Jakob Dupont, MD Memorial Sloan Kettering Cancer Center
Publications of Results:
Layout table for additonal information Identifier: NCT00045266    
Other Study ID Numbers: REGENERON-VGF-ST-0105
CDR0000256462 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 3, 2016
Last Verified: June 2016
Keywords provided by Regeneron Pharmaceuticals:
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult Burkitt lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent mantle cell lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult Burkitt lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV mantle cell lymphoma
unspecified adult solid tumor, protocol specific
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
stage IV small lymphocytic lymphoma
stage IV marginal zone lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma
Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases