Aflibercept in Treating Patients With Myelodysplastic Syndromes

Exclusion Criteria

• •Evidence of active malignancies other than squamous cell or basal cell carcinoma of the skin
• •Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
• •History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in the study
• •Serious or non-healing wound, ulcer, or bone fracture
• •History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
• •Significant traumatic injury within the past 28 days
• •Clinically significant cardiovascular disease, including any of the following:
• •* History of cerebrovascular accident (CVA) within the past 6 months
• •* Uncontrolled hypertension, defined as blood pressure \> 150/100 mm Hg or systolic BP \> 180 mm Hg if diastolic blood pressure \< 90 mm Hg (on at least 2 repeated determinations on separate days) within the past 3 months
• •* Myocardial infarction or unstable angina within the past 6 months
• •* New York Heart Association class III or IV congestive heart failure, serious cardiac arrhythmia requiring medication, or unstable angina pectoris within the past 6 months
• •Clinically significant peripheral vascular disease within the past 6 months
• •Pulmonary embolism, deep vein thrombosis (DVT), or other thromboembolic event within the past 6 months
• •Evidence of bleeding diathesis or coagulopathy
• •Concurrent uncontrolled illness including, but not limited to, ongoing or active infection or psychiatric illness/social situation that would limit compliance with study requirements
• •Prior cytotoxic chemotherapy for MDS
• •Molecular therapy or immunosuppressive agents (including steroids) within the past 3 weeks
• •Other prior antiangiogenesis agents
• •Coronary artery bypass graft (CABG) within the past 6 months
• •Valproic acid should be discontinued at least 24 hours before aflibercept administration, unless needed for seizure control
• •Major surgical procedure or open biopsy within the past 28 days
• •Core biopsy (other than bone marrow biopsy) within the past 7 days
• •Anticipation of need for major surgical procedures during the course of the study
• •Patients may not be receiving any other investigational agents