Overview

Cephalon Decitabine, Arsenic Trioxide and Ascorbic Acid for Myelodysplastic Syndrome

Status:
Completed
Trial end date:
2010-04-01
Target enrollment:
0
Participant gender:
All
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 trioxide and ascorbic acid is safe.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Duke University
Collaborators:
Cephalon
Eisai Inc.
Treatments:
Arsenic Trioxide
Ascorbic Acid
Azacitidine
Decitabine
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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