Aflibercept in Treating Patients With Myelodysplastic Syndromes

Stopped early · Phase 2

Conditions studied: Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative, Chronic Myelomonocytic Leukemia, de Novo Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Previously Treated Myelodysplastic Syndromes, Secondary Myelodysplastic Syndromes

In brief

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

Key facts

Study ID

NCT00509249

Run by

National Cancer Institute (NCI)

People needed

18

Starts

2007-09-01

Expected to finish

2010-12-01

Last updated by the study team

2015-01-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have histologically or cytologically confirmed myelodysplastic syndromes (MDS), including any of the following:
• Secondary MDS
• MDS/myeloproliferative disorders (MPD) (e.g., chronic myelomonocytic leukemia or atypical chronic myeloid leukemia)
• IPSS scores of 0.5 or greater (≥ INT-1) OR transfusion dependent despite use of growth factors
• No more than 20% blasts in the marrow
• Patients who have not responded after 3 courses of hypomethylating agents (azacitidine or decitabine) OR; who are unable to tolerate hypomethylating agents OR who refused to receive hypomethylating agents are eligible for this study
• ECOG performance status ≤ 2 (Karnofsky ≥ 60%)
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
• AST/ALT ≤ 2.5 x ULN
• Creatinine ≤ 1.5 x ULN OR creatinine clearance ≥ 60 mL/min
• Urine protein:creatinine ratio < 1 OR urine protein < 500 mg by 24-hour urine collection
• PT INR ≤ 1.5
• Patients with PT INR > 1.5 on full-dose anticoagulants (e.g., warfarin) are eligible provided both of the following criteria are met:
• Patient has an in-range INR (usually between 2 and 3) and is on a stable dose of oral anticoagulant or low molecular weight heparin
• Patient has no active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
• Not pregnant or nursing
• Fertile patients must use effective contraception during and for at least 6 months after completion of study treatment
• Prior DNA-demethylating agent therapy or lenalidomide therapy allowed
• Prior treatment with other molecular agents, such as thalidomide, valproic acid, or imatinib mesylate allowed

You may not qualify if…

• 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

Where it is running

• City of Hope Medical Center — Duarte, California, United States

Full record on ClinicalTrials.gov

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