A PHASE I COOPERATIVE AGREEMENT PEDIATRIC TRIAL OF MITOXANTRONE, ETOPOSIDE AND PSC-833 (PSC-ME) THERAPY IN PATIENTS WITH RELAPSED AND REFRACTORY ACUTE LEUKEMIA

Date de début de l'étude : 1 janvier 1997

DISEASE CHARACTERISTICS: Acute myeloid leukemia (AML) in one of the following categories: First relapse if initial CR less than 6 months Refractory to first or second induction with daunomycin, cytarabine, and thioguanine (DAT) or other anthracycline-containing regimens Relapse following bone marrow transplantation provided good trilineage engraftment followed transplant and greater than 6 months since transplant Presentation with secondary AML or AML evolving from myelodysplastic syndrome --Acute lymphocytic leukemia in one of the following categories: In second or subsequent relapse or failed second or later induction attempts regardless of prior remissions Relapsed following bone marrow transplantation provided good trilineage engraftment followed transplant and greater than 6 months since transplant No isolated CNS or extramedullary relapse PATIENT CHARACTERISTICS: Age: Under 22 at diagnosis Performance status: Karnofsky 50-100% (ECOG 0-2) Lansky 40-100% (in patients under 12 years of age) Life expectancy: At least 8 weeks Bilirubin less than 1.5 mg/dL ALT less than twice normal Creatinine normal for age (within 2 standard deviations) OR glomular filtration rate at least 70 mL/min Albumin at least 3 g/dL Ejection fraction greater than 50% at rest or with 5% increase with exercise OR shortening fraction greater than 27% by echocardiogram No history of clinical heart failure No uncontrolled infection No anticonvulsant therapy No history of allergic reactions or anaphylaxis to etoposide not remediable by premedication Not pregnant or nursing Fertile patients must use effective contraception Third percentile weight for height PRIOR CONCURRENT THERAPY: At least 4 weeks since chemotherapy and recovered Prior cumulative anthracycline dose no greater than 360 mg per square meter Hydroxyurea therapy allowed just prior to study for rapidly rising blast count