Comparison of Three Treatment Regimens in Treating Patients With Relapsed or Refractory Acute Myelogenous Leukemia

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically proven acute myelogenous leukemia of one of the following types:
• •* Acute myeloblastic leukemia (FAB type M0, M1, or M2)
• •* Acute promyelocytic leukemia (FAB type M3) allowed if ineligible for an ECOG M3 protocol or if no tretinoin or arsenic trioxide therapy is planned
• •* Acute myelomonocytic leukemia (FAB type M4)
• •* Acute monocytic leukemia (FAB type M5)
• •* Acute erythroleukemia (FAB type M6)
• •* Acute megakaryocytic leukemia (FAB type M7)
• •Must meet 1 of the following criteria:
• •* Relapse less than 6 months after first complete remission (CR)
• •* Relapse 6-12 months after first CR
• •* Refractory to conventional initial induction chemotherapy (no more than 2 courses) or first reinduction (no more than 1 course)
• •* Must have marrow documentation of residual leukemia after chemotherapy (for at least 2 weeks duration)
• •* Second or greater relapse
• •No relapse greater than 1 year after achieving first CR
• •Blast cells must be CD33 positive
• •Prior CNS leukemia allowed if there is currently documentation of no CNS involvement on CSF examination (i.e., negative CSF by lumbar puncture)
• •PATIENT CHARACTERISTICS:
• •Age:
• •18 and over
• •Performance status:
• •ECOG 0-2
• •Life expectancy:
• •Not specified
• •Hematopoietic:
• •See Disease Characteristics
• •Hepatic:
• •Bilirubin no greater than 2.0 mg/dL\*
• •SGOT less than 2 times upper limit of normal\* NOTE: \*Unless due to leukemia infiltration
• •Renal:
• •Creatinine no greater than 2.0 mg/dL
• •Cardiovascular:
• •See Chemotherapy
• •No myocardial infarction within the past 3 months
• •No significant congestive heart failure
• •No significant cardiac arrhythmia
• •Cardiac ejection fraction normal by MUGA scan or echocardiogram
• •Resting ejection fraction at least 50% or at least 5% increase with exercise
• •Shortening fraction at least 24% or normal by echocardiogram
• •Other:
• •Not pregnant or nursing
• •Fertile patients must use effective contraception
• •No concurrent organ damage or other medical problems that would precludestudy therapy
• •No concurrent evidence (including positive blood or deep tissue cultures or stains) of invasive fungal infection
• •No hypersensitivity to ingredients of gemtuzumab ozogamicin or daunorubicin liposomal
• •No other active tumor that would interfere with study therapy or increase risk
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy:
• •No prior gemtuzumab ozogamicin
• •Chemotherapy:
• •See Disease Characteristics
• •See Biologic therapy
• •No prior daunorubicin liposomal or topotecan
• •Prior doxorubicin (no greater than 300 mg/m2), daunorubicin (no greater than 300 mg/m2), idarubicin (no greater than 100 mg/m2), or mitoxantrone (no greater than 100 mg/m2) allowed if left ventricular function is adequate
• •At least 4 weeks since prior chemotherapy except patients who are refractory to conventional initial induction chemotherapy
• •Prior hydroxyurea allowed within 4 weeks prior to beginning study
• •Hydroxyurea must be discontinued at least 24 hours prior to beginning study
• •Endocrine therapy:
• •Not specified
• •Radiotherapy:
• •At least 4 weeks since prior radiotherapy except patients who are refractory to conventional initial induction chemotherapy
• •Surgery:
• •Not specified