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

University Health Network, Toronto

Status and phase

Completed

Phase 1

Conditions

Acute Myeloid Leukemia

Treatments

Drug: Tigecycline

Study type

Interventional

Funder types

Other

Identifiers

NCT01332786

OZM-029

Details and patient eligibility

About

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.

Full description

Relapsed and refractory hematologic malignancies have poor responses to standard therapy and are associated with a poor prognosis. For example, relapsed acute myeloid leukemia (AML) is a highly aggressive and resistant disease, particularly when associated with first complete response (CR) duration of less than 12 months. Thus, there is an urgent need for new agents in relapsed and refractory hematologic malignancies such as acute leukemia. In elderly patients, where the tolerance of aggressive induction therapy is often poor and curative options such as bone marrow transplantation HSCT are not available, the need for effective non-aggressive drug regimens for AML is even greater.

Tigecycline is a glycylcycline derivative of tetracycline. Tigecycline is currently indicated for the treatment of complicated skin and skin structure infections, and complicated intra-abdominal infections. This clinical trial is a Phase I dose escalation study of tigecycline in patients with relapsed or refractory AML or those with newly diagnosed disease not eligible for induction chemotherapy.

Enrollment

27 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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