Arsenic Trioxide and Cyclophosphamide in Treating Patients with Relapsed or Refractory Acute Myeloid Leukemia

Inclusion Criteria

• World Health Organization (WHO)-confirmed AML, other than acute promyelocytic leukemia (APL), with no standard treatment options available
• Relapsed or refractory (resistant) disease, as defined by standard criteria * Relapsed: Bone marrow blasts >= 5%, reappearance of blasts in the blood, or development of extramedullary disease following achievement of complete remission (CR)/complete remission with incomplete recovery of blood counts (CRi)/complete remission with incomplete recovery of platelets (CRp)/morphologic leukemia free state (MLFS) * Refractory (resistant): Failure to achieve CR/CRi/MLFS in subjects who survive >= 7 days following completion of initial treatment, with evidence of persistent leukemia by blood and/or bone marrow examination
• > 14 days since any prior therapy for AML excluding hydroxyurea
• Willing and able to understand and voluntarily sign a written informed consent
• Able to adhere to the study visit schedule and other protocol requirements
• Women of childbearing potential must use an acceptable form of birth control for 28 days prior to beginning study treatment, through the duration of study treatment, and for 3 months after discontinuing study treatment

Exclusion Criteria

• New York Heart Association class III or IV heart failure
• Unstable angina pectoris
• Significant uncontrolled cardiac arrhythmias, including ventricular arrhythmias, congenital long QT syndrome, symptomatic atrial fibrillation, symptomatic bradycardia, right bundle branch block plus left anterior hemiblock or bifasicular block
• Corrected QT interval (QTc) > 500 ms, uncorrectable by managing electrolytes and medications, using the Fridericia's correction (QTcF) formula
• Active acute graft versus (vs.) host disease >= grade 2 or active extensive chronic graft versus host disease (GVHD)
• Relapse after allogeneic stem cell transplantation prior to post-transplant day 30
• Active central nervous system (CNS) involvement of leukemia (lumbar puncture not required to rule out CNS involvement if not suspected)
• Uncontrolled psychiatric illness that would limit compliance with requirements
• Pregnant or breast feeding females
• Either creatinine > 2.0 mg/dL or creatinine clearance < 30 mL/min
• Total bilirubin > 3 x institutional upper limit of normal (ULN) (unless documented Gilbert’s syndrome)
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x institutional upper limit of normal (ULN), unless felt to be due to disease involvement
• Other medical or psychiatric illness or organ dysfunction or laboratory abnormality which, in the opinion of the investigator, would compromise the subject’s safety or interfere with data interpretation