Phase II Study of Bexarotene in Patients With Acute Myeloid Leukemia

A Phase II Study of Bexarotene in Patients With Acute Myeloid Leukemia

The purpose of this study is to evaluate the activity of bexarotene, a retinoic acid class drug, in patients with Acute Myeloid Leukemia (AML) that has returned after or is resistant to standard chemotherapy or are otherwise not eligible for conventional chemotherapy. Retinoic acids are a class of drugs related to Vitamin A, and have a wide range of effects within normal and malignant cells that affect cell growth and cell death.

Inclusion Criteria:

• Age >= 18 years
• Confirmed diagnosis of AML as proven by bone marrow biopsy
• Must have received prior induction therapy with conventional chemotherapy and/or Mylotarg or otherwise not eligible for conventional chemotherapy
• ECOG performance status of 0-2
• Recovered from toxicities of prior chemotherapy

Exclusion Criteria:

• History of pancreatitis
• Active alcohol abuse
• Taken bexarotene in the past
• WBC > 10,000/uL at time of enrollment
• Cytotoxic therapy within the past 14 days other than hydrea, low dose cytarabine or low dose Mylotarg
• Significant organ disfunction: total bilirubin > 3x ULN, AST or ALT >3 x ULN, creatinine > 3 mg/dL, on blood pressure supporting medications or mechanical ventilation
• Active participant in any other investigational treatment study for AML
• Life expectancy of less than 1 month
• Use of blood growth factors (G-CSF, GM-CSF, Aranesp, erythropoietin, or Neumega) within 1 week prior to treatment initiation
• Uncontrolled hyperlipidemia
• Known history of HIV
• Known active CNS involvement with AML
• Women of childbearing potential or active breast feeding