Decitabine in Treating Patients With Myelodysplastic Syndromes or Acute Myeloid Leukemia
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
About this trial
This is an interventional treatment trial for Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Eligibility Criteria
Inclusion Criteria: One of the following diagnoses: High-risk myelodysplastic syndromes (MDS) Acute myeloid leukemia (AML) De novo, secondary, or relapsed disease Any number of prior regimens for primary or relapsed disease Ineligible for or refuses aggressive management Measurable disease, defined as: More than 5% blasts in bone marrow of patients with MDS More than 30% blasts in bone marrow of patients with AML Involvement of cerebrospinal fluid allowed Performance status - ECOG 0-2 Performance status - Karnofsky 60-100% See Disease Characteristics Bilirubin no greater than 1.25 times upper limit of normal (ULN) AST and/or ALT no greater than 1.25 times ULN Creatinine less than 1.7 mg/dL Creatinine clearance at least 60 mL/min No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia No ongoing or active infection No other uncontrolled illness that would preclude study participation No psychiatric illness or social situation that would preclude study compliance No prior allergic reactions to compounds of similar chemical or biological composition to decitabine No other active malignancy Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception At least 4 weeks since prior biologic therapy (e.g., interferon, filgrastim [G-CSF], sargramostim [GM-CSF], thrombopoietin, or epoetin alfa) No concurrent hematopoietic growth factors (GM-CSF, thrombopoietin, or epoetin alfa) No concurrent prophylactic G-CSF Prior intrathecal cytarabine allowed for patients with cerebrospinal fluid involvement At least 4 weeks since prior chemotherapy (except low-dose chemotherapy administered to maintain WBC counts) (6 weeks for nitrosoureas or mitomycin) and recovered At least 24 hours since prior hydroxyurea Concurrent intrathecal cytarabine allowed for patients with cerebrospinal fluid involvement No prior radiotherapy greater than 3,000 cGy to marrow-producing areas At least 4 weeks since prior radiotherapy and recovered Prior investigational therapy allowed No other concurrent investigational agents No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent anticancer therapy
Sites / Locations
- Princess Margaret Hospital Phase 2 Consortium
Arms of the Study
Arm 1
Experimental
Treatment (decitabine)
Patients receive decitabine IV over 3 hours twice daily OR IV over 1 hour once daily on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of decitabine until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.