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Sponsors and Collaborators: |
Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00601991 |
RATIONALE: Aflibercept may stop the growth of cancer cells by blocking blood flow to the cancer.
PURPOSE: This phase II trial is studying how well aflibercept works in treating patients with advanced refractory, relapsed, or untreated acute myeloid leukemia.
Condition | Intervention | Phase |
Leukemia |
Drug: aflibercept Procedure: biopsy Procedure: flow cytometry Procedure: immunoenzyme technique Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: pharmacological study |
Phase II |
MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic |
Drug Information available for: | Aflibercept |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Multi-Center Phase 2 Study of VEGF Trap as a Single Agent in Acute Myeloid Leukemia |
Estimated Enrollment: | 41 |
Study Start Date: | December 2007 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo bone marrow and blood sample collection periodically for pharmacokinetic/pharmacodynamic studies. Samples are analyzed for peak plasma-free aflibercept levels after the first infusion, trough plasma-free and bound aflibercept levels prior to each subsequent infusion and 60 days after the last infusion, and anti-aflibercept antibody via ELISA methods; circulating endothelial cells (CEC's) via ELISA and flow cytometry to determine if there is correlation between changes in circulating endothelial cells and changes in bone marrow blast percentage (i.e., disease response); myeloblast expression of VEGFR-1 and VRGFR-2 via immunohistochemistry (IHC); endothelial progenitor cells colony forming units (EPC-CFU's) to determine via in situ staining if changes in circulating endothelial progenitors following treatment with aflibercept correlates with disease response, and if there is a subpopulation of patients identified by pre-treatment circulating EPC-CFU's that may benefit from aflibercept; and bone marrow microvessel density (MVD) determination via immunohistochemistry.
After completion of study treatment, patients are followed for 8 weeks.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Acute myeloid leukemia (AML), as defined by WHO criteria and documented by morphologic examination of bone marrow aspirate and biopsy, including the following stages:
AML that has relapsed following one or more histologically documented complete remissions
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Clinically significant cardiovascular disease within the past 6 months, including any of the following:
PRIOR CONCURRENT THERAPY:
Full-dose anticoagulation (e.g., warfarin) with PT/INR > 1.5 allowed provided that both of the following criteria are met:
Prior and concurrent hydroxyurea allowed for blast control
Vanderbilt-Ingram Cancer Center |
National Cancer Institute (NCI) |
Study Chair: | Madan Jagasia, MD | Vanderbilt-Ingram Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Responsible Party: | Vanderbilt-Ingram Cancer Center ( Madan Jagasia ) |
Study ID Numbers: | CDR0000582163, VU-VICC-HEM-0652, VU-VICC-061069 |
First Received: | January 17, 2008 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00601991 |
Health Authority: | Unspecified |
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