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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01332786
Recruitment Status : Completed
First Posted : April 11, 2011
Last Update Posted : April 15, 2015
University of Kansas
Memorial Sloan Kettering Cancer Center
University of California, Los Angeles
Information provided by (Responsible Party):
University Health Network, Toronto

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: Tigecycline Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study Evaluating the Tolerance and Biologic Activity of Intravenous Infusions of Tigecycline in Patients With Relapsed or Refractory AML
Study Start Date : March 2011
Actual Primary Completion Date : October 2014
Actual Study Completion Date : January 2015

Arm Intervention/treatment
Experimental: Tigecycline Drug: Tigecycline

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
Other Name: Tygacil

Primary Outcome Measures :
  1. Toxicity evaluated according to CTCAE version 4.03 [ Time Frame: Reviewed at each visit and assessed at the end of each 3-week cycle ]

Secondary Outcome Measures :
  1. Response rate assessment of tigecycline through laboratory assessments [ Time Frame: Assessed at the end of each 3-week cycle for the study duration ]
    Bone marrow assessment, absolute neutrophil count, platelet counts

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01332786

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United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
United States, Kansas
The University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
University of Kansas
Memorial Sloan Kettering Cancer Center
University of California, Los Angeles
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Study Director: Aaron Schimmer, MD University Health Network, Toronto

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Responsible Party: University Health Network, Toronto Identifier: NCT01332786     History of Changes
Other Study ID Numbers: OZM-029
First Posted: April 11, 2011    Key Record Dates
Last Update Posted: April 15, 2015
Last Verified: April 2015

Keywords provided by University Health Network, Toronto:

Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action