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