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CompletedNCT00896662Updated Apr 25, 2016

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

An observational study in Lymphoma and Solid Tumor, sponsored by Vanderbilt-Ingram Cancer Center. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-25.

Sponsored by Vanderbilt-Ingram Cancer Center · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
9
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

  • Lymphoma
  • Solid Tumor

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Keywords

  • 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
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In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 9 is below the median of 136 across 625 observational studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Vanderbilt-Ingram Cancer Center is the lead sponsor of 220 studies on the registry; 32 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 18 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

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

Exclusion Criteria:

  • none listed

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
9 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • Otherimmunologic technique

    immunologic technique

  • Otherlaboratory biomarker analysis

    laboratory biomarker analysis

  • Otherpharmacological study

    pharmacological study

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. Correlation of aflibercept level with host antigen presenting cell phenotype at baseline

    Time frame: at days 15, 29 and 64

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00896662
Lead sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Jeffrey A. Sosman, MD (Professor of Medicine, Medical Oncologist, Vanderbilt-Ingram Cancer Center) — Principal investigator
First posted
May 12, 2009
Start date
Jan 2005
Primary completion
Oct 2007
Completion
Aug 2008
Last update
Apr 25, 2016

Study contacts

Jeffrey A. Sosman, MD
study chair · Vanderbilt-Ingram Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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