NCT00896662

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2005

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
Last Updated

April 25, 2016

Status Verified

April 1, 2016

Enrollment Period

2.7 years

First QC Date

May 9, 2009

Last Update Submit

April 21, 2016

Conditions

LymphomaSolid Tumor

Keywords

unspecified adult solid tumor, protocol specificrecurrent adult Burkitt lymphomastage IV adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomarecurrent adult immunoblastic large cell lymphomastage IV adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomastage IV adult lymphoblastic lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomarecurrent mantle cell lymphomastage IV mantle cell lymphomarecurrent marginal zone lymphomasplenic marginal zone lymphomastage IV marginal zone lymphomanodal marginal zone B-cell lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuerecurrent small lymphocytic lymphomastage IV small lymphocytic lymphoma

Outcome Measures

Primary Outcomes (3)

  • Effect of in vivo aflibercept on the presence of different populations of dendritic cells (DC) and immature cells (ImC)

    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)

    at days 15, 29 and 64

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

    at days 15, 29 and 64

Interventions

immunologic techniqueOTHER

immunologic technique

laboratory biomarker analysisOTHER

laboratory biomarker analysis

pharmacological studyOTHER

pharmacological study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • none listed
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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.

MeSH Terms

Conditions

LymphomaBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, FollicularLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

Immunologic Techniques

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Jeffrey A. Sosman, MD

    Vanderbilt-Ingram Cancer Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine, Medical Oncologist

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

January 1, 2005

Primary Completion

October 1, 2007

Study Completion

August 1, 2008

Last Updated

April 25, 2016

Record last verified: 2016-04