Cephalon Decitabine, Arsenic Trioxide and Ascorbic Acid for Myelodysplastic Syndrome
Completed · Phase 2
Conditions studied: Myelodysplastic Syndrome
In brief
This will be an open-label, non-randomized trial pilot phase II trial open to patients with myelodysplastic syndrome. The purpose of the study is to find out if the combination of decitabine, arsenic trioxide and ascorbic acid is safe.
Key facts
- Study ID
- NCT00621023
- Run by
- Duke University
- People needed
- 7
- Starts
- 2007-11-01
- Expected to finish
- 2010-04-01
- Last updated by the study team
- 2013-02-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Established diagnosis of MDS (de novo or secondary) fitting either the French American British Cooperative Group (FAB) or World Health Organization (WHO) classification systems as determined by a complete blood count (CBC) and bone marrow biopsy. Patients with >20% bone marrow blasts but <30% bone marrow blasts who would be classified as refractory anemia with excess blasts (RAEB-t) in the FAB and acute myeloid leukemia (AML) in the WHO systems are still eligible for this study. Patients with low risk MDS (IPSS scores low or intermediate -1 (INT-1) must be transfusion dependent to be eligible. Transfusion dependent will be defined as having 2 or more transfusion events within a 90 day period.
- Eastern Oncology Cooperative Group (ECOG) or WHO performance status of 0-2 (Appendix)
- Able to provide written informed consent.
You may not qualify if…
- Pregnant females
- AML defined as > 30% bone marrow blasts.
- Any malignant disease within the past 2 years, except cervical carcinoma, basal cell carcinoma of the skin, and squamous cell carcinoma of the skin..
- Off all prior treatment for MDS for at least 4 weeks from entry.
- Off any investigational agents for at least 4 weeks from entry.
- Uncontrolled cardiac disease or congestive heart failure as defined by New York Heart Association criteria of Class III or greater.
- Uncontrolled pulmonary disease.
- Uncontrolled or active viral or bacterial infection. All infections must have been fully treated with antibiotics.
- HIV +
- Lab values as specified in the protocol
Where it is running
- Duke University Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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