Status:
COMPLETED
Cephalon Decitabine, Arsenic Trioxide and Ascorbic Acid for Myelodysplastic Syndrome
Lead Sponsor:
Duke University
Collaborating Sponsors:
Cephalon
Eisai Inc.
Conditions:
Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
Conventional therapy for MDS has been poor at best. Supportive care with transfusion therapy and antibiotics have remained an option for all patients with myelodysplastic syndrome (MDS). The only kno...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00621023
Start Date
November 1 2007
End Date
April 1 2010
Last Update
February 4 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Duke University Medical Center
Durham, North Carolina, United States, 27710