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
  Purpose

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 Intervention Phase
Cancer
Biological: ziv-aflibercept
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Enrollment: 25
Study Start Date: January 2004
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082823

Locations
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
Investigators
Principal Investigator: William P. Tew, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00082823     History of Changes
Other Study ID Numbers: REGENERON-VGFT-ST-0304, MSKCC-03138, CDR0000360846
Study First Received: May 14, 2004
Last Updated: April 15, 2013
Health Authority: United States: Federal Government

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:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Immunoblastic
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on August 25, 2014