DT388IL3 Fusion Protein in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes

DISEASE CHARACTERISTICS:

• Diagnosis of 1 of the following:
• Histologically or morphologically confirmed acute myeloid leukemia (AML), meeting 1 of the following criteria:
• Relapsed or refractory AML after treatment with ≥ 1 prior conventional induction therapy
• Patients in early first relapse must not have a matched donor available and/or be ineligible for allogeneic stem cell transplantation
• Poor-risk AML, as defined by any of the following criteria:
• Treatment-related AML, unless associated with favorable cytogenetics (e.g., inversion 16, t[16;16], t[8;21], t[15;17]), and ineligible for stem cell transplantation
• Antecedent hematological disease (e.g., myelodysplastic syndromes, myelofibrosis, or polycythemia vera) that evolved to AML (≥ 20% blasts) and ineligible for stem cell transplantation
• De novo AML (must be > 70 years of age)
• AML with unfavorable cytogenetics (e.g., abnormalities of chromosomes -7, -5, 7q-, or 5q-; complex [≥ 3] abnormalities; or abnormalities of 11q23, excluding t[9;11], t[9;22], inversion 3, t[3;3], and t[6;9]), regardless of age, and ineligible for allogeneic stem cell transplantation
• High-risk myelodysplastic syndromes diagnosed by morphologic, histochemical, or cell surface marker criteria
• Resistant or intolerant to chemotherapy
• Ineligible for or unwilling to undergo immediate allogeneic stem cell transplantation
• Bone marrow index (i.e., percent cellularity × percent blasts) ≤ 40% at time of treatment
• No active CNS leukemia

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Bilirubin ≤ 1.5 mg/dL
• ALT and AST < 2.5 times upper limit of normal
• Albumin ≥ 3 mg/dL
• Creatinine ≤ 1.5 mg/dL
• LVEF ≥ 50%
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 2 weeks after completion of study treatment
• No complicated medical or psychiatric problems that would preclude study compliance
• No concurrent serious uncontrolled infection or disseminated intravascular coagulation
• No myocardial infarction within the past 6 months
• No allergies to diphtheria toxin
• No requirement for oxygen

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No other concurrent antineoplastic drugs
• No concurrent radiotherapy
• No concurrent corticosteroids as antiemetics
• No concurrent hematopoietic growth factors (e.g., epoetin alfa, interleukin-11, filgrastim [G-CSF], or sargramostim [GM-CSF])
• No concurrent intravenous immunoglobins