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