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

Inclusion Criteria

• •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