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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00896662
• Other study ID #: VICC PHI0433
• Secondary ID: VU-VICC-PHI-0433
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: April 20, 2011
• Start date: January 2005
• Est. completion date: August 2008

Study information

• Verified date: April 2011
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: August 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lymphoma
• Solid Tumor

Intervention

Other:
• immunologic technique
immunologic technique
• laboratory biomarker analysis
laboratory biomarker analysis
• pharmacological study
pharmacological study

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	Correlation of aflibercept level with host antigen presenting cell phenotype at baseline		at days 15, 29 and 64	No