GTI-2040 and High-Dose Cytarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia

Inclusion criteria

* Histologically confirmed acute myeloid leukemia according to the WHO classification * Relapsed or refractory disease, meeting 1 of the following criteria: * Unresponsive to initial treatment * Recurrent disease after treatment with prior conventional or high-dose chemotherapy with or without stem cell support * CNS involvement allowed provided there are no residual leukemic cells detected in the cerebrospinal fluid after intrathecal or radiation chemotherapy * Performance status - ECOG 0-2 * At least 4 weeks * Bilirubin no greater than 2 times upper limit of normal\* (ULN) (unless due to Gilbert's syndrome) * AST and ALT no greater than 3 times ULN\* * Creatinine no greater than 1.5 mg/dL\* * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * Resting ejection fraction at least 50%\* * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior allergy to study medications * No ongoing or active infection requiring IV antibiotics * No other concurrent uncontrolled illness * No serious medical or psychiatric illness that would preclude giving informed consent * More than 4 weeks since prior chemotherapy (except hydroxyurea) (6 weeks for nitrosoureas or mitomycin) * No other concurrent chemotherapy * No concurrent hormonal therapy except steroids for adrenal failure and hormones for non-disease-related conditions (e.g., insulin for diabetes) * More than 4 weeks since prior radiotherapy * No concurrent palliative radiotherapy * Prior therapy with antisense oligonucleotides allowed provided no toxic effects were experienced that were directly attributable to the antisense agents * No other concurrent investigational agents * No other concurrent anticancer therapy * No concurrent chronic systemic anticoagulant therapy for medical conditions (e.g., prior deep vein thrombosis or atrial fibrillation) * Concurrent heparin to maintain central line patency (i.e., catheter flush) is allowed * No concurrent combination antiretroviral therapy for HIV-positive patients