A Phase II Randomized Trial of Immunologic and Chemotherapeutic Agents for Treatment of 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