Vincristine Sulfate Liposome in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Condition: Recurrent Adult Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Vincristine Sulfate Liposome; Laboratory Biomarker Analysis
Intervention description: Given via injection; Correlative studies
Intervention MeSH terms: Vincristine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This pilot phase II trial studies how well vincristine sulfate liposome works in treating
      patients with acute myeloid leukemia that has returned after a period of improvement or has
      not responded to previous treatment. Drugs used in chemotherapy, such as vincristine sulfate
      liposome, work in different ways to stop the growth of cancer cells, either by killing the
      cells, by stopping them from dividing, or by stopping them from spreading. Liposomal
      encapsulation prolongs bioavailability (proportion of drug that enters the circulation when
      introduced into the body) of vincristine sulfate, and may increase its delivery to cancer
      cells with fewer side effects.
    

Eligibility criteria:

        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)