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