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

PRIMARY OBJECTIVES:

I. To determine the feasibility of administering vincristine sulfate liposome injection
(VSLI) to relapsed or refractory acute myeloid leukemia (AML) patients having failed, refused
or not a candidate for at least one chemotherapy salvage regimen.

II. To observe the hematologic improvement-rate of VSLI in this patient population.

SECONDARY OBJECTIVES:

I. To observe the overall survival of patients treated with VSLI. II. To observe the response
rate (complete remission [CR], complete remission with incomplete count recovery [CRi],
partial response [PR], and morphologic leukemia free state [MLFS]) of VSLI in this patient
population.

OUTLINE:

Patients receive vincristine sulfate liposome via injection on days 1, 8, 15, and 22. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for up to 6 months.

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

- Bilirubin =< 3 x UNL

- Glomerular filtration rate (GFR) > 50 ml/min/1.72 m^2 or creatinine < 2 g/dL

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 hepatic function (aspartate aminotransferase [AST/SGOT] =< 3 x
upper normal limit [UNL], alanine aminotransferase [ALT/SGPT] =< 3 x UNL [=< 5 x ULN
if liver metastases present], bilirubin =< 1.5 x UNL)

- Evidence of inadequate renal function (creatinine > 2 g/dL)