Chronic Myelomonocytic Leukemia Clinical Trial
Official title:
A Phase II Study of VEGF Trap (NSC 724770) in Patients With MDS
This phase II trial is studying how well aflibercept works in treating patients with myelodysplastic syndromes. Aflibercept may be able to carry cancer-killing substances directly to myelodysplastic syndrome cells. It may also stop the growth of cancer cells by blocking blood flow to the cancer
OBJECTIVES:
I. To determine the antitumor activity of aflibercept as assessed by the hematological
response rate.
II. To determine overall and progression-free survival in patients with myelodysplastic
syndromes.
III. To assess hematologic improvement and time to leukemic transformation. IV. To assess
the toxicity profile of aflibercept in this patient population. V. To perform correlative
studies to better understand the ability of aflibercept to reach and modulate its respective
targets.
OUTLINE: This is a multicenter study.
Patients will receive aflibercept IV over 1 hour on day 1. Courses repeat every 14 days in
the absence of disease progression or unacceptable toxicity.
Blood and bone marrow samples will be obtained periodically for pharmacokinetic and
biomarker correlative studies. Pharmacokinetic analysis by ELISA; anti-aflibercept antibody
measurements; analysis of VEGF and VEGFR expression; and analysis of gene expression by
quantitative PCR will be conducted. The effect of aflibercept on apoptosis and proliferation
of CD34+ cells will also be analyzed by flow cytometry based assays.
After completion of study treatment, patients are followed periodically.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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