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