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

NCT ID: NCT00896662

Last Updated: 2016-04-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 9 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2008-08-31

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.

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.

Conditions

Lymphoma; Solid Tumor

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

immunologic technique

immunologic technique

Intervention Type: OTHER

laboratory biomarker analysis

laboratory biomarker analysis

Intervention Type: OTHER

pharmacological study

pharmacological study

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Vanderbilt-Ingram Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey A. Sosman, MD

Professor of Medicine, Medical Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey A. Sosman, MD

Role: STUDY_CHAIR

Vanderbilt-Ingram Cancer Center

Other Identifiers

VU-VICC-PHI-0433

Identifier Type: -

Identifier Source: secondary_id

VU-IRB-040852

Identifier Type: -

Identifier Source: secondary_id

VICC PHI 0433

Identifier Type: -

Identifier Source: org_study_id