Clinical trial NCT00896662: Analysis of Dendritic Phenotype and Function of Patients Receiving VEGF-Trap on VGFT-ST-0202
Official title: Analysis of Dendritic Phenotype and Function of Patients Receiving VEGF-Trap on VGFT-ST-0202
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Solid Tumor
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
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Effect of in vivo aflibercept on the presence of different populations of dendritic cells (DC) and immature cells (ImC)
timeFrame: at days 15, 29 and 64
measure: 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)
timeFrame: at days 15, 29 and 64
measure: Correlation of aflibercept level with host antigen presenting cell phenotype at baseline
timeFrame: at days 15, 29 and 64
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Jeffrey A. Sosman, MD
role: STUDY_CHAIR
References: