Decitabine (DAC) w/ or w/o Valproic Acid (VPA) in Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)
Condition: Myelodysplastic Syndrome; Acute Myelogenous Leukemia
MeSH terms: Leukemia; Preleukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Syndrome
Intervention: Decitabine; Valproic Acid
Intervention description: 20 mg/m^2 IV over 1 hour daily for 5 days.; 50 mg/kg orally daily for 7 days
Intervention MeSH terms: Decitabine; Valproic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 153.0
Sex: All
Healthy volunteers: No
Keywords: Decitabine; Dacogen; 5-AZA; Valproic Acid; Myelodysplastic Syndrome; Acute Myelogenous Leukemia; MDS; AML

Summary:

      The goal of this clinical research study is to find out if decitabine, given with or without
      valproic acid, can help to control AML or MDS. The safety of both treatments will also be
      studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with MDS and > 5% blasts or IPSS risk intermediate or high; patients with
             CMML; patients with AML who are age 60 or older. No prior intensive chemotherapy or
             high-dose ara-C (> 1g/m2). No prior azacytidine for 3 cycles or more or prior
             decitabine for 2 cycles or more. Prior biologic therapies, targeted therapies, or
             single agent chemotherapy allowed.Patients must have been off chemotherapy for 2 weeks
             prior to entering this study and recovered from the toxic effects of that therapy,
             unless there is evidence of rapidly progressive disease.

          2. Continued from #1: Hydroxyurea is permitted for control of counts prior to treatment.
             Procrit, granulocyte colony-stimulating factor (GCSF) are allowed before therapy.
             Procrit, GCSF or other growth factors are permitted on therapy. Use of hydroxyurea
             with rapidly proliferative disease is allowed for the first two weeks on therapy.

          3. Performance 0-2 (ECOG). Adequate liver function (bilirubin of < 2mg/dl) and renal
             function (creatinine < 2mg/dl). Adequate cardiac functions (NYHA cardiac III-IV
             excluded). ALT < 2.5x institutional upper limit of normal.

          4. Signed informed consent.

        Exclusion Criteria:

          1. Nursing and pregnant females. Patients of childbearing potential should practice
             effective methods of contraception. Should a woman become pregnant or suspect she is
             pregnant while participating in this study, she should inform her treating physician
             immediately.

          2. Active and uncontrolled infections.

          3. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, or
             psychiatric illness/social situations that would limit compliance with study
             requirements.

          4. Known ornithine transcarbamylase disorder.

          5. Patients requiring continuous valproic acid treatment for the control of seizure
             disorders.