Laboratory-Treated Donor Cord Blood Cell Infusion Following Combination Chemotherapy in Treating Younger Patients With Relapsed or Refractory Acute Myeloid Leukemia

Inclusion Criteria:

• Patients must have a diagnosis of AML according to World Health Organization (WHO) classification with >= 5% of disease in bone marrow (BM), with or without extramedullary disease or biopsy-proven isolated myeloid sarcoma (myeloblastoma, chloroma, including leukemia cutis) in the absence of marrow involvement

• AML:

  • If relapse AML:

    • Must have a prior diagnosis of AML and be in 1st or greater relapse
    • Must not have received prior reinduction therapy for this relapse

  • If primary refractory AML:

    • Must have had a prior diagnosis of AML and
    • Must not have received more than 3 previous induction attempts
  • Patients must be classified as central nervous system (CNS)1 or CNS 2 and without clinical signs of CNS leukemia such as cranial nerve palsy; patients with CNS 3 disease are not eligible
• Must have a Lansky or Karnofsky performance status of >= 50; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
• Patients must have recovered from the acute toxicity of all prior chemotherapy; patients may not have received cytotoxic chemotherapy within 2 weeks of first dose of G-CSF (filgrastim) therapy, with exception of hydroxyurea, which is allowed for up to 24 hours prior to first dose of G-CSF, and intrathecal chemotherapy, which is allowed prior to, or in the 1st 72 hours after start of G-CSF therapy

• The following amounts of time must have elapsed prior to entry on study:

  • 2 weeks from local radiation therapy (XRT)
  • 8 weeks from prior craniospinal or if > 50% of the pelvis has been irradiated
  • 6 weeks must have elapsed if other bone marrow radiation has occurred
• Creatinine within normal range for age (per institutional defined lab value ranges)
• Direct bilirubin =< 1.5 upper limit of normal (ULN) age unless elevation thought to be due or hepatic infiltration by the hematologic malignancy
• Alanine aminotransferase (ALT) < 5 x ULN age
• Adequate cardiac function as defined as shortening fraction of > 27% OR ejection fraction of > 50%
• Patients must have a calculated QT (QTc) interval < 450 ms on baseline echocardiogram
• Patients must demonstrate a respiratory rate that is within normal limits for age, measured when afebrile and at rest (measured for a full minute) and pulse oximetry > 93% on room air
• Signed informed consent
• Patient must have a life expectancy of at least 2 months
• Females of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
• Females of childbearing potential and males should agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation

Exclusion Criteria:

• Recipient of prior allogeneic hematopoietic stem cell transplant (HCT)
• Patients with history of Down's syndrome, Fanconi anemia or other known marrow failure condition
• Patients with central nervous system (CNS) 3 disease or symptomatic CNS2 disease are not eligible
• Patients currently receiving other investigational drugs are not eligible
• Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol with the exception of intrathecal chemotherapy; this includes the tyrosine kinase inhibitor sorafenib which must not be initiated until patient demonstrates count recovery
• Patients with a systemic fungal, bacterial, viral, or other infection not controlled despite appropriate antibiotics or other treatment; uncontrolled systemic infections require infectious disease consultation for verification
• Patients who are platelet refractory prior to initiation of protocol therapy; platelet refractoriness is defined by platelet count < 50K when platelet count is obtained 1 hour post platelet transfusion
• Pregnant or lactating patients
• Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results