Vincristine Sulfate Liposome in Treating Patients with Relapsed or Refractory Acute Myeloid Leukemia

Inclusion Criteria

• Patients must have histologically or cytologically documented relapsed and/or refractory acute myeloid leukemia
• Patients must be ineligible for, refused or having failed at least one previous salvage regimen
• Eastern Cooperative Oncology Group (ECOG) performance status of =< 3
• Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device), and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation
• Fertile men must practice effective contraceptive methods during the study period, unless documentation of infertility exists
• Mentally competent, ability to understand and willingness to sign the informed consent form
• No serious medical illness that would potentially increase patients’ risk for toxicity
• No active central nervous system (CNS) disease
• No active uncontrolled bleeding/bleeding diathesis
• No condition or abnormality which may, in the opinion of the investigator, compromise the safety of the patient
• No unwillingness or inability to follow protocol requirements
• No evidence of ongoing, uncontrolled infection
• No requirement for immediate palliative treatment of any kind including surgery
• No option for immediate bone marrow transplant unless patient refuses this therapy
• Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) =< 3 x upper normal limit (UNL), alanine aminotransferase (ALT)/serum glutamate pyruvate transaminase (SGPT) =< 3 x UNL, values =< 2 weeks
• Bilirubin =< 3 x UNL, values =< 2 weeks
• Glomerular filtration rate (GFR) > 50 ml/min/1.72 m^2 or creatinine < 2 g/dL, values =< 2 weeks

Exclusion Criteria

• Serious medical illness or severe debilitating pulmonary disease that would potentially increase the patients’ risk for toxicity
• Patients with persistent grade 3 or higher prior vincristine (VCR) (vincristine sulfate)-related neuropathy
• Patients with active central nervous system (CNS) disease
• Any active uncontrolled bleeding, and any patients with a bleeding diathesis (e.g., active peptic ulcer disease)
• Pregnant women, or women of child-bearing potential not using reliable means of contraception
• Lactating females
• Fertile men unwilling to practice contraceptive methods during the study period
• Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
• Unwilling or unable to follow protocol requirements
• Evidence of ongoing, uncontrolled infection
• Patients with known human immunodeficiency virus (HIV) infection
• Requirement for immediate palliative treatment of any kind including surgery
• Evidence of inadequate renal function (creatinine > 2 g/dL)