Decitabine for Older or Unfit Patients With Acute Myeloid Leukemia (AML)
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Decitabine
Intervention description: 20 mg/m2 by vein daily for either 5 or 10 days.
Intervention MeSH terms: Decitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Leukemia; Acute myeloid leukemia; AML; Response rates; Decitabine; Dacogen

Summary:

      The goal of this clinical research study is to compare how well 2 different dosing schedules
      of decitabine may help control AML.

      Decitabine is designed to damage the DNA (the genetic material) of cells, which may cause
      cancer cells to die.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with previously untreated AML (by the World Health Organization (WHO)
             criteria, i.e. >/= 20% blasts) Prior biologic therapies (such as growth factors) and
             targeted therapies administered for the treatment of prior myelodysplastic syndrome
             are allowed, with the exception of hypomethylating agents 5-azacytidine or decitabine.
             Patients must have been off such therapy for 1 week prior to entering this study and
             recovered from the toxic effects of that therapy, unless there is evidence of rapidly
             progressive disease. Hydroxyurea, and a single dose of cytarabine up to 3 g/m2, is
             permitted for control of counts prior to treatment.

          2. Patients >/= 60 are eligible if not a candidate for standard cytarabine plus
             anthracycline chemotherapy as determined by Kantarjian's score (Appendix D) Patients
             younger than 60 may also be included if felt not to be a candidate for intensive
             anthracycline plus cytarabine based chemotherapy.

          3. Performance 0-3 (ECOG).

          4. Adequate liver function (Total bilirubin of < 2 mg/dl) unless due to hemolysis,
             leukemia organ infiltration or Gilbert's syndrome and renal function (creatinine < 2.5
             mg/dl).

          5. Signed informed consent

        Exclusion Criteria:

          1. Nursing and pregnant females. Female patients of childbearing potential and male
             patients should practice effective methods of contraception such as double barrier
             method. Should a woman become pregnant or suspect she is pregnant while participating
             in this study, she should inform her treating physician immediately. Negative urine
             pregnancy test (women of childbearing potential)

          2. Active and uncontrolled infections.

          3. Uncontrolled intercurrent illness including, but not limited to, symptomatic
             congestive heart failure, unstable angina pectoris, active significant other cancers
             requiring chemotherapy and/or radiation therapy within past 6 months (excluding
             non-melanoma skin cancer) or psychiatric illness/social situations that would limit
             compliance with study requirements.