Belinostat in Treating Patients With Myelodysplastic Syndromes

Completed · Phase 2

Conditions studied: de Novo Myelodysplastic Syndromes, Previously Treated Myelodysplastic Syndromes, Secondary Myelodysplastic Syndromes

In brief

This phase II trial is studying how well belinostat works in treating patients with myelodysplastic syndromes. Belinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.

Key facts

Study ID

NCT00357162

Run by

National Cancer Institute (NCI)

People needed

21

Starts

2006-05-01

Expected to finish

2010-12-01

Last updated by the study team

2014-05-20

Who can join

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

You may qualify if…

• Histologically confirmed myelodysplastic syndromes (MDS)
• De novo or secondary MDS
• Patients with < 5 % bone marrow blasts must meet ≥ 1 of the following criteria:
• Symptomatic anemia with either hemoglobin < 10.0 g/dL or required RBC transfusions within the past 3 months
• Thrombocytopenia with ≥ 2 platelet counts < 50,000/mm³ or significant hemorrhage requiring platelet transfusions
• Neutropenia with ≥ 2 absolute neutrophil counts < 1,000/mm³
• No acute myeloid leukemia (≥ 20% bone marrow blasts)
• ECOG performance status 0-2
• Life expectancy > 12 weeks
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST ≤ 2 times ULN
• Creatinine ≤ 2.0 mg/dL
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to PXD101
• No HIV positivity
• QTc interval ≤ 500 msec
• No long QT syndrome
• No significant cardiovascular disease, including any of the following:
• Unstable angina pectoris
• Uncontrolled hypertension
• Congestive heart failure related to primary cardiac disease
• Condition requiring anti-arrhythmic therapy
• Ischemic or severe valvular heart disease

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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