Decitabine in Treating Patients With Previously Untreated Acute Myeloid Leukemia
Condition: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Secondary Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: decitabine; laboratory biomarker analysis; pharmacological study; high performance liquid chromatography; microarray analysis; RNA analysis; mass spectrometry; DNA methylation analysis; matrix-assisted laser desorption/ionization time of flight mass spectrometry
Intervention description: Given IV; Correlative studies; Correlative studies; Correlative studies; Correlative studies; Correlative studies; Correlative studies; Correlative studies; Correlative studies
Intervention MeSH terms: Decitabine; Azacitidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well decitabine works in treating patients with
      previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as decitabine,
      work in different ways to stop the growth of cancer cells, either by killing the cells or by
      stopping them from dividing
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed acute myeloid leukemia (AML) meeting 1 of
             the following criteria:

               -  At least 60 years of age and not a candidate for or refused standard induction
                  treatment

               -  Poor risk cytogenetics

               -  AML following antecedent hematologic disorder

               -  Therapy-related AML

               -  Secondary AML

          -  No granulocytic sarcoma as sole site of disease

          -  No active CNS disease or CNS relapse

          -  ECOG performance status 0-2

          -  Life expectancy > 6 months

          -  Total bilirubin < 2.0 mg/dL

          -  Creatinine < 2.0 mg/dL

          -  AST and ALT < 2.5 times upper limit of normal

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No NYHA class III or IV congestive heart failure

          -  No uncontrolled infection

          -  No history of allergic reactions attributed to compounds of similar chemical or
             biologic composition to decitabine that are not easily managed

          -  No other uncontrolled illness including, but not limited to, any of the following:

               -  Symptomatic congestive heart failure

               -  Unstable angina pectoris

               -  Serious cardiac arrhythmia

               -  Psychiatric illness or social situations that would preclude compliance with
                  study requirements

          -  No active second malignancy involving the blood or marrow or likely to progress and
             require therapy in the next 6 months

          -  No prior therapy for AML except emergency leukapheresis or hydroxyurea for
             leukocytosis

          -  No prior azacitidine or decitabine

          -  No prior cytarabine or other conventional chemotherapy agents for antecedent
             hematologic disorders

               -  Prior myeloid growth factors, recombinant erythropoietin, thalidomide, or
                  lenalidomide allowed

          -  No concurrent palliative radiotherapy

          -  No other concurrent investigational agents

          -  No other concurrent direct anti-leukemia therapy

          -  No concurrent combination antiretroviral therapy for HIV-positive patients