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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00082823
First received: May 14, 2004
Last updated: April 15, 2013
Last verified: December 2009

May 14, 2004
April 15, 2013
January 2004
May 2008   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00082823 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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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.

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.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cancer
Biological: ziv-aflibercept
Not Provided
Lockhart AC, Rothenberg ML, Dupont J, Cooper W, Chevalier P, Sternas L, Buzenet G, Koehler E, Sosman JA, Schwartz LH, Gultekin DH, Koutcher JA, Donnelly EF, Andal R, Dancy I, Spriggs DR, Tew WP. Phase I study of intravenous vascular endothelial growth factor trap, aflibercept, in patients with advanced solid tumors. J Clin Oncol. 2010 Jan 10;28(2):207-14. Epub 2009 Nov 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
Not Provided
May 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00082823
REGENERON-VGFT-ST-0304, MSKCC-03138, CDR0000360846
Not Provided
Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
National Cancer Institute (NCI)
Principal Investigator: William P. Tew, MD Memorial Sloan-Kettering Cancer Center
Regeneron Pharmaceuticals
December 2009

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