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

Completed · Phase 1

Conditions studied: Acute Myeloid Leukemia

In brief

The purpose of this study is to determine whether tigecycline is safe and which dosage is most effective in the treatment of patients with acute myeloid leukemia.

Key facts

Study ID

NCT01332786

Run by

University Health Network, Toronto

People needed

27

Starts

2011-03-01

Expected to finish

2015-01-01

Last updated by the study team

2015-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California, Los Angeles — Los Angeles, California, United States
• The University of Kansas Medical Center — Kansas City, Kansas, United States
• Princess Margaret Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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