A Study of Decitabine Given Subcutaneously to Adults With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)
Condition: Myelodysplastic Syndrome
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Intervention: decitabine; decitabine
Intervention description: Schedule A: decitabine will be administered subcutaneously (SQ) daily for 3 consecutive days (Days 1 to 3) every 28 days. The dose will be 20 mg/m^2/day. One course will be considered 28 days.; Schedule B: decitabine will be administered SQ every 7 days for 21 days (Days 1, 8, and 15) followed by 7 days without an administration of decitabine. The dose will be 20 mg/m^2/day. One course will be considered 28 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: 67.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Myelodysplastic Syndrome; Decitabine; Dacogen; MGI PHARMA, Inc.

Summary:

      The purpose of this study is to determine the effectiveness and safety of two different dose
      schedules of DACOGEN® (decitabine) for Injection in patients with Myelodysplastic Syndromes
      (MDS).
    

Eligibility criteria:

        Inclusion Criteria:

        Each patient must meet the following criteria to be enrolled in this study:

          1. Male or female patients age 18 years and older.

          2. Patients must sign an institutional review board (IRB)-approved informed consent form,
             and understand the investigational nature of this study and its potential hazards
             prior to initiation of any study-specific procedures or treatment.

          3. Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

          4. Adequate renal and hepatic function (creatinine < 2 times upper limit of normal, total
             bilirubin of < 2 times upper limit of normal, and AST and ALT ≤ 2 times upper limit of
             normal) unless proven to be related to disease infiltration.

          5. Female patients need a negative serum or urine pregnancy test within 7 days prior to
             study drug administration (applies only if patient is of childbearing potential.
             Non-childbearing is defined as ≥ 1 year postmenopausal or surgically sterilized).

          6. Women of childbearing potential and men must use contraception. Men and women must
             continue birth control for the duration of the study.

          7. Patients with Low or Intermediate-1 Risk MDS by the International Prognostic Scoring
             System (IPSS) classification.

        Exclusion Criteria:

        Patients who meet any of the following criteria will be excluded from the study:

          1. Women who are pregnant or nursing.

          2. Those who have received prior therapy with decitabine.

          3. Prior therapy with azacitidine (Vidaza®).

          4. Those who received growth factor support or lenalidomide in the 30 days prior to the
             first dose of decitabine.

          5. Those who have received an investigational agent 30 days prior to the first dose of
             decitabine.

          6. Patients with active, uncontrolled, systemic infection considered opportunistic, life
             threatening or clinically significant; or any severe, concurrent disease, which, in
             the judgment of the Investigator and after discussion with the Sponsor and Primary
             Investigator, would make the patient inappropriate for study entry.