Cephalon Decitabine, Arsenic Trioxide and Ascorbic Acid for Myelodysplastic Syndrome
Condition: Myelodysplastic Syndrome
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Intervention: Decitabine, Arsenic Trioxide and Ascorbic Acid
Intervention description: Subjects receive decitabine 20 mg/m2 IV over one hour for days1-5 of each cycle, and arsenic trioxide 0.25 mg/kg IV for days 1-5 of cycle 1 followed by 0.25 mg/kg twice weekly (Mon-Thursday or Tues-Fri) for all remaining cycles. Patients will have transfusion and supportive care therapy administered per the treating physician's discretion. Patients with a response after 4 cycles of therapy may choose to continue on two more cycles of decitabine with arsenic and ascorbic acid given only during the first week of those two additional cycles.
Intervention MeSH terms: Ascorbic Acid; Decitabine; Arsenic Trioxide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Myelodysplastic syndrome; MDS

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.
    

Eligibility 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