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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.
 
ClinicalTrials.gov Identifier: NCT00082823
Recruitment Status : Completed
First Posted : May 19, 2004
Last Update Posted : June 3, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Study Description
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Brief Summary:

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

Detailed Description:

OBJECTIVES:

Primary

  • Determine the safety and tolerability of intravenous VEGF Trap in patients with relapsed or refractory advanced solid tumors or non-Hodgkin's lymphoma.

Secondary

  • 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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)

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • No severe or uncontrolled hematologic condition

Hepatic

  • Not specified

Renal

  • No severe or uncontrolled renal condition

Cardiovascular

  • No severe or uncontrolled cardiovascular condition

Pulmonary

  • No severe or uncontrolled pulmonary condition

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

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

Chemotherapy

  • Not specified

Endocrine therapy

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

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • 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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00082823


Locations
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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
Sponsors and Collaborators
Regeneron Pharmaceuticals
National Cancer Institute (NCI)
Investigators
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Principal Investigator: William P. Tew, MD Memorial Sloan Kettering Cancer Center
More Information
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Publications of Results:

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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00082823    
Other Study ID Numbers: REGENERON-VGFT-ST-0304
MSKCC-03138
CDR0000360846 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: May 19, 2004    Key Record Dates
Last Update Posted: June 3, 2016
Last Verified: June 2016
Keywords provided by Regeneron Pharmaceuticals:
recurrent grade 1 follicular lymphoma
stage IV grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
stage IV grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
stage IV grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
recurrent adult diffuse large cell lymphoma
stage IV adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
stage IV adult diffuse mixed cell lymphoma
recurrent adult immunoblastic large cell lymphoma
stage IV adult immunoblastic large cell lymphoma
recurrent adult Burkitt lymphoma
 stage IV adult Burkitt lymphoma
recurrent mantle cell lymphoma
stage IV mantle cell lymphoma
recurrent adult lymphoblastic lymphoma
stage IV adult lymphoblastic lymphoma
unspecified adult solid tumor, protocol specific
recurrent adult soft tissue sarcoma
advanced adult primary liver cancer
recurrent adult primary liver cancer
recurrent cervical cancer
stage IVA cervical cancer
stage IVB cervical cancer
fallopian tube cancer
ovarian sarcoma
recurrent ovarian epithelial cancer
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases