Pilot Study of Feasibility of Outpatient Daily High Dose Cytarabine as Consolidation Therapy for Older Patients With Acute Myeloid Leukemia (AML)

Inclusion Criteria:

Inclusion Criteria for Outpatient Administration of HiDAC

* Unequivocal diagnosis of AML (\>20% blasts in the bone marrow based on the WHO classification), excluding M3 (acute promyelocytic leukemia).
* Documented complete remission (CR) following induction chemotherapy as defined as (18):
* Bone marrow with \<5% blasts; absence of blasts with Auer rods
* Absolute neutrophil count \>1000/mcL
* Platelets \>100,000/mcL
* Independence of red cell transfusions
* Absence of extramedullary disease
* Age ≥ 55 years.
* Relapsed AML patients are eligible as long as they meet other inclusion and exclusion criteria.
* Good performance status of (ECOG 0-2), see appendix 15.3.
* Adequate renal and hepatic function (Cr ≤ 1.2, alkaline phosphatase \<3.0 x upper limit of normal, total bilirubin \<1.5 x upper limit of normal unless there is a history of Gilbert's disease).

Inclusion Criteria for Quality of Life Comparison Group

* All patients decline to participate as an out-patient or who are not eligible for participation in the out-patient portion of the study will be approached to participate in the QOL comparison.
* Age ≥ 18 years

Exclusion Criteria:

Exclusion Criteria for All Patients

* Active, uncontrolled viral, bacterial, or fungal infection.
* Documented CNS leukemia.
* If unable to do a reliable cerebellar examination for monitoring of neurotoxicity.
* History of prior autologous or allogeneic bone marrow/stem cell transplant.
* New York Heart Association class III/IV congestive heart failure, see appendix 15.4, or active ischemic heart disease.
* Pregnant or lactating women (women and men of childbearing age should use effective contraception).
* Concomitant active malignancy requiring treatment with cytotoxic chemotherapy or radiation therapy. (Ongoing hormonal therapy for the treatment of malignancy would not exclude patients from this trial.)
* Time period of greater than 10 weeks between initiation of induction chemotherapy and day 1 of the first cycle of consolidation chemotherapy.
* Patients seropositive for infection with Human Immunodeficiency Virus (HIV) are excluded due to potential for serious infectious complications associated with T-cell suppressive therapy in these patients.