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

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborators: Memorial Sloan Kettering Cancer Center; University of California, Los Angeles; University of Kansas
• Treatments: Minocycline; Tigecycline

Criteria

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