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