Low-Dose Daunorubicin Hydrochloride in Treating Patients with Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

Inclusion Criteria

• Ability to understand and the willingness to sign a written informed consent or have parental consent
• Pathological confirmation by bone marrow documenting the following: * Acute myeloid leukemia (AML) which has relapsed after complete remission * AML which has been refractory to two prior induction attempts * Acute lymphoblastic leukemia (ALL) which has relapsed after complete remission * ALL which has been refractory to two prior induction attempts
• Disease status allows delay of additional anti-leukemia therapy for the duration of the study (hydroxyurea is allowed for control of white blood cell count [WBC] throughout study)
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3
• Able to adhere to the study visit schedule and other protocol requirements
• Cardiac ejection fraction >= 45% by echocardiogram (ECHO)
• Serum alanine aminotransferase or aspartate aminotransferase < 3 times the upper limit of normal (ULN)
• Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: ** Has not undergone a hysterectomy or bilateral oophorectomy or ** Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)

Exclusion Criteria

• Concurrent use of conventional or investigational anticancer agents, except hydroxyurea
• Patient has received chemotherapy or radiotherapy within 2 weeks prior to entering the study or has not recovered from adverse events due to agents administered more than 2 weeks earlier, with the exception of hydroxyurea
• Patients with known active uncontrolled central nervous system (CNS) leukemia
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to daunorubicin
• Patients with a total lifetime anthracycline exposure exceeding the equivalent of 900 mg/m^2 of daunorubicin
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Unwilling or unable to undergo serial bone marrow aspirate/biopsy
• Pregnant or nursing