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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University of Kansas
Memorial Sloan-Kettering Cancer Center
University of California, Los Angeles
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01332786
First received: March 31, 2011
Last updated: March 16, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Acute Myeloid Leukemia
Drug: Tigecycline
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Toxicity evaluated according to CTCAE version 4.03 [ Time Frame: Reviewed at each visit and assessed at the end of each 3-week cycle ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response rate assessment of tigecycline through laboratory assessments [ Time Frame: Assessed at the end of each 3-week cycle for the study duration ] [ Designated as safety issue: No ]
    Bone marrow assessment, absolute neutrophil count, platelet counts


Estimated Enrollment: 28
Study Start Date: March 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01332786

Contacts
Contact: Andre Schuh, FRCPC, MD 416-9446-6518 andre.schuh@uhn.ca

Locations
United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Rose Malone, RN, NP    310-794-0242    Rmalone@mednet.ucla.edu   
Principal Investigator: Gary J Schiller, MD, FACP         
United States, Kansas
The University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Lisa Wright, RN    913-588-0343    lwright6@kumc.edu   
Principal Investigator: Suman Kambhampati, MD         
Canada, Ontario
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Deborah Sanfelice, RN    416-946-4501 ext 2867    deborah.sanfelice@uhn.on.ca   
Principal Investigator: Andre Schuh, MD         
Sponsors and Collaborators
University Health Network, Toronto
University of Kansas
Memorial Sloan-Kettering Cancer Center
University of California, Los Angeles
Investigators
Study Director: Aaron Schimmer, MD University Health Network, Toronto
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01332786     History of Changes
Other Study ID Numbers: OZM-029
Study First Received: March 31, 2011
Last Updated: March 16, 2012
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by University Health Network, Toronto:
AML

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Tigecycline
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 21, 2014