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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Dosage Form: one-hour intravenous infusion Dosage levels, frequency, duration: (3-week cycles) * Level 1: 50 mg daily x 10 doses; 1 week rest * Level 2: 100 mg daily x 10 doses; 1 week rest * Level 3: 150 mg daily x 10 doses; 1 week rest * Level 4: 200 mg daily x 10 doses 1 week rest * Level 5: 250 mg daily x 10 doses; 1 week rest * Level 6: 300 mg daily x 10 doses; 1 week rest * Level 7: 350 mg daily x 10 doses; 1 week rest
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
Toxicity evaluated according to CTCAE version 4.03
Time frame: Reviewed at each visit and assessed at the end of each 3-week cycle
Response rate assessment of tigecycline through laboratory assessments
Bone marrow assessment, absolute neutrophil count, platelet counts
Time frame: Assessed at the end of each 3-week cycle for the study duration
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