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

April 21, 2016 updated by: Jeffrey A. Sosman, MD, Vanderbilt-Ingram Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

9

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
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
at days 15, 29 and 64

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (ACTUAL)

October 1, 2007

Study Completion (ACTUAL)

August 1, 2008

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (ESTIMATE)

May 12, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 25, 2016

Last Update Submitted That Met QC Criteria

April 21, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VICC PHI 0433
  • VU-VICC-PHI-0433
  • VU-IRB-040852

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lymphoma

Clinical Trials on laboratory biomarker analysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe