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Analysis of Dendritic Phenotype and Function of Patients Receiving VEGF-Trap on VGFT-ST-0202

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00896662
First Posted: May 12, 2009
Last Update Posted: April 25, 2016
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jeffrey A. Sosman, MD, Vanderbilt-Ingram Cancer Center
  Purpose

RATIONALE: Studying the dendritic cells in samples of blood from patients with cancer receiving aflibercept may help doctors learn about the effect of aflibercept on dendritic cells.

PURPOSE: This laboratory study is evaluating dendritic cells in patients with advanced solid tumors or non-Hodgkin lymphoma receiving aflibercept on clinical trial VGFT-ST-0202.


Condition Intervention
Lymphoma Solid Tumor Other: immunologic technique Other: laboratory biomarker analysis Other: pharmacological study

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Analysis of Dendritic Phenotype and Function of Patients Receiving VEGF-Trap on VGFT-ST-0202

Resource links provided by NLM:


Further study details as provided by Jeffrey A. Sosman, MD, Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • Effect of in vivo aflibercept on the presence of different populations of dendritic cells (DC) and immature cells (ImC) [ Time Frame: at days 15, 29 and 64 ]
  • Effect of aflibercept administration on DC function based on ability to stimulate antigen specific proliferative (allogeneic and tetanus toxoid) and cytolytic T cell responses (influenza) [ Time Frame: at days 15, 29 and 64 ]
  • Correlation of aflibercept level with host antigen presenting cell phenotype at baseline [ Time Frame: at days 15, 29 and 64 ]

Biospecimen Retention:   Samples Without DNA
50cc of peripheral blood will be collected in CPT tubes for mononuclear cell isolation and 10cc in SST tubes for plasma collection.

Enrollment: 9
Study Start Date: January 2005
Study Completion Date: August 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: immunologic technique
    immunologic technique
    Other: laboratory biomarker analysis
    laboratory biomarker analysis
    Other: pharmacological study
    pharmacological study
Detailed Description:

OBJECTIVES:

  • Evaluate the effect of in vivo aflibercept on the presence of different populations of dendritic cells (DC) and immature cells (ImC) in the peripheral blood of cancer patients by characterizing the time course (kinetics) of the improvement in antigen presenting cell (APC) phenotype (decline in DC/ImC ratio) occurring early and late after aflibercept administration.
  • Evaluate the effect of aflibercept administration on DC function based on ability to stimulate antigen specific proliferative (allogeneic and tetanus toxoid) and cytolytic T cell responses (influenza) by characterizing the time course (kinetics) of the improvement in APC function occurring early and late after aflibercept administration.
  • Explore the relationship of baseline aflibercept level and host APC phenotype.

OUTLINE: This is a multicenter study.

Patients undergo phlebotomy and blood collection at baseline and on days 15, 29, and 57. Samples are analyzed for dendritic cell phenotype, subpopulations, maturation status, and function in terms of ability to activate autologous T cells.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Up to 25 patients; three at each dose level achieved in order to gain additional information regarding safety, pharmacokinetics, and biological effect of VEGF Trap given intravenously.

Patients with a solid tumor and is consented and eligible for enrollment onto VGFT-ST-0202. Patients who are willing to undergo phlebotomy prior to treatment, and 14 and 28 and 57 days following initial dose of VEGF-Trap. Patients with an Hgb ≥10gm at the time of blood draw.

Criteria

Inclusion Criteria:

  • Diagnosis of advanced solid tumor or non-Hodgkin lymphoma and enrolled on clinical trial VGFT-ST-0202
  • Hemoglobin ≥ 10 g/dL
  • Willing to undergo phlebotomy

Exclusion Criteria:

  • none listed

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
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): NCT00896662


Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Jeffrey A. Sosman, MD Vanderbilt-Ingram Cancer Center
  More Information

Responsible Party: Jeffrey A. Sosman, MD, Professor of Medicine, Medical Oncologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00896662     History of Changes
Other Study ID Numbers: VICC PHI 0433
VU-VICC-PHI-0433
VU-IRB-040852
First Submitted: May 9, 2009
First Posted: May 12, 2009
Last Update Posted: April 25, 2016
Last Verified: April 2016

Keywords provided by Jeffrey A. Sosman, MD, Vanderbilt-Ingram Cancer Center:
unspecified adult solid tumor, protocol specific
recurrent adult Burkitt lymphoma
stage IV adult Burkitt lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
recurrent adult immunoblastic large cell lymphoma
stage IV adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
stage IV adult lymphoblastic lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
recurrent mantle cell lymphoma
stage IV mantle cell lymphoma
recurrent marginal zone lymphoma
splenic marginal zone lymphoma
stage IV marginal zone lymphoma
nodal marginal zone B-cell lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
recurrent small lymphocytic lymphoma
stage IV small lymphocytic lymphoma

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases