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| ID | Type | Description | Link |
|---|---|---|---|
| VU-VICC-PHI-0433 | |||
| VU-IRB-040852 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| immunologic technique | Other | immunologic technique | ||
| laboratory biomarker analysis | Other | laboratory biomarker analysis | ||
| pharmacological study | Other | pharmacological study |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
PRIOR CONCURRENT THERAPY:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey A. Sosman, MD | Vanderbilt-Ingram Cancer Center | Study Chair |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D002051 | Burkitt Lymphoma |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008228 | Lymphoma, Non-Hodgkin |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D007158 | Immunologic Techniques |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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50cc of peripheral blood will be collected in CPT tubes for mononuclear cell isolation and 10cc in SST tubes for plasma collection.
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D015448 | Leukemia, B-Cell |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |