Safety Study Evaluating Intravenous Infusions of Tigecycline to Treat Acute Myeloid Leukemia

Inclusion Criteria:

• Age >18 years
• Diagnosis of relapsed or refractory AML for which all potentially curative or standard salvage therapy options have been exhausted; OR AML without prior treatment who are not eligible for induction chemotherapy as defined as age > or equal to 80 or age > 70 with poor risk cytogenetics (3 or more abnormalities, -5/del(5q), 3q abnormalities, or -7) or stable co-morbidities that would preclude induction chemotherapy such as LVEF less than 40% and/or DlCO less than 60% expected
• ECOG 0-2 performance status
• Biochemical values within the following range
• Serum creatinine <2x upper limit of normal
• Total bilirubin <1.5x upper limit of normal
• AST and ALT <2x upper limit of normal
• Recovery from non-hematologic toxicity from prior chemotherapy
• Able and willing to provide informed consent

Exclusion Criteria:

• Allergy to tetracycline or minocycline
• Uncontrolled intercurrent illness such as uncontrolled diabetes or active uncontrolled infection
• Active systemic bacterial, fungal, or viral infection
• Concomitant use of linezolid or chloramphenicol that are known to inhibit mitochondrial protein synthesis
• Pregnant or breast feeding
• Known active CNS involvement with AML
• Neurologic symptoms related to uncontrolled illnesses or unexplained causes
• Psychiatric illness that would limit compliance with study
• Receiving systemic chemotherapy other than hydroxyurea to control circulating blast counts. Concomitant hydroxyurea is permitted, but only in the first cycle of therapy
• Prior therapy with tigecycline as an anti-cancer therapy or any use of the drug in the last month
• Use of other investigational anti-leukemic therapy within 14 days of registration