Pharmacokinetic Trial of Decitabine (Dacogen) Administered as a 3-hour Infusion to Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
Condition: Leukemia
MeSH terms: Leukemia; Preleukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes
Intervention: Decitabine (Dacogen)
Intervention description: Intravenous injection; total dose-per-cycle was 135 mg/m^2 of decitabine.
Intervention MeSH terms: Decitabine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute myelogenous leukemia; myelodysplastic Syndrome; cancer

Summary:

      The purpose of this study is to determine the pharmacokinetics (PK) of decitabine
      administered to patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
    

Eligibility criteria:

        Inclusion Criteria:

        Each patient had to meet the following criteria to be eligible for the study:

          1. Patients with MDS (de novo or secondary) must have been 60 years or older and have had
             disease fitting any of the recognized French-American-British classifications OR
             chronic myelomonocytic leukemia (with white blood cell [WBC] <12,000/μL) AND have had
             an International Prognostic Scoring System score of ≥1.5 as determined by complete
             blood count, bone marrow assessment and bone marrow cytogenetics within 30 days of
             study entry.

          2. Patients with AML (≥30% bone marrow blasts) must have been age 18 years or older and
             had previously received standard induction chemotherapy and/or had failed approved
             therapies.

          3. Must have had Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

          4. Must have signed an Institutional Review Board (IRB)-approved informed consent form,
             indicating his/her awareness of the investigational nature of this study and its
             potential hazards prior to initiation of any study-specific procedures or treatment.

          5. Must have had adequate renal and hepatic function (creatinine ≤2.0 mg/dL, total
             bilirubin <2.0 mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase
             (ALT) <3.0 X institutional upper limit of normal).

          6. Must have had life expectancy of at least 12 weeks.

          7. Must have recovered from all toxic effects of all prior therapy before entry into this
             study.

        Exclusion Criteria:

          1. Patients with MDS must not have been candidates for high-dose chemotherapy, bone
             marrow or stem cell transplant.

          2. Must not have had acute promyelocytic leukemia (M3 classification).

          3. Must not have received immunosuppressive therapy for 30 days prior to study entry.

          4. Must not have had central nervous system (CNS) leukemia.

          5. Must not have received systemic corticosteroids, interferon, interleukins or other
             hormonal therapy within 30 days prior to study entry. Use of corticosteroids (topical
             and inhaled corticosteroids) was permitted and prophylactic steroids may have been
             used to treat or prevent transfusion reactions.