Lestaurtinib, Cytarabine, and Idarubicin in Treating Younger Patients With Relapsed or Refractory Acute Myeloid Leukemia

You may be eligible if

• DISEASE CHARACTERISTICS:
• Diagnosis of acute myeloid leukemia (AML) according to FAB classification
• * At least 5% blasts in the bone marrow, with or without extramedullary disease
• In first relapse after induction therapy OR refractory to induction therapy with ≤ 1 attempt at remission induction
• * Patients who are in a first relapse \> 1 year from their initial diagnosis of AML are excluded from the dose-finding phase of the study, but are eligible for the efficacy phase
• * First relapse after hematopoietic stem cell transplantation (HSCT) allowed provided patient has no evidence of active graft-versus-host disease (GVHD) and is at least 4 months posttransplantation
• Positive for a FLT3 activating mutation (internal tandem duplication or kinase domain point mutation) using standard polymerase chain reaction-based procedures at any time in the course of illness
• Treatment-related AML allowed
• PATIENT CHARACTERISTICS:
• Karnofsky performance status (PS) 50-100% (\> 16 years of age) OR Lansky PS 50-100% (≤ 16 years of age)
• Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR serum creatinine based on age and gender as follows:
• * Creatinine no greater than 0.4 mg/dL (1 month to \< 6 months of age)
• * Creatinine no greater than 0.5 mg/dL (6 months to \< 1 year of age)
• * Creatinine no greater than 0.6 mg/dL (1 year to \< 2 years of age)
• * Creatinine no greater than 0.8 mg/dL (2 years to \< 6 years of age)
• * Creatinine no greater than 1 mg/dL (6 years to \< 10 years of age)
• * Creatinine no greater than 1.2 mg/dL (10 years to \< 13 years of age)
• * Creatinine no greater than 1.4 mg/dL (females) or 1.5 mg/dL (males) (13 years to \< 16 years of age)
• * Creatinine no greater than 1.4 mg/dL (females) or 1.7 mg/dL (males) (16 years of age and over)
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• ALT \< 5 times ULN (unless it is related to leukemic involvement)
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by radionuclide angiogram
• PRIOR CONCURRENT THERAPY:
• Recovered from all prior therapy
• No prior cumulative anthracycline doses exceeding 450 mg/m\^2 daunorubicin equivalents
• * Patients who relapse after receiving treatment on protocol COG-AAML03P1 or COG-AAML0531 (300 mg/m\^2 of daunorubicin hydrochloride and 48 mg/m\^2 of mitoxantrone hydrochloride) allowed provided they have not received any additional anthracyclines
• At least 14 days since prior cytotoxic therapy
• * Hydroxyurea allowed to decrease the WBC prior to starting protocol treatment
• * No concurrent hydroxyurea
• At least 7 days since prior biologic agents
• At least 14 days since prior monoclonal antibody therapy
• Radiotherapy to chloromas allowed
• * Irradiated lesion may not be used to assess tumor response
• No other concurrent chemotherapy, investigational therapy, immunomodulating agents, or steroids
• * Steroids used as an antiemetic allowed
• * Prophylactic intrathecal cytarabine allowed
• No concurrent CYP3A4,5 inhibitors, including any of the following:
• * Azole antifungals (e.g., fluconazole or voriconazole)
• * Cyclosporine
• * Erythromycin
• * Clarithromycin
• * Troleandomycin
• * HIV protease inhibitors
• * Nefazodone
• No concurrent CYP3A4,5 inducers, including any of the following:
• * Carbamazepine
• * Dexamethasone
• * Rifampin
• * Phenobarbital
• * Phenytoin
• * Hypericum perforatum (St. John's wort)