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Imatinib Mesylate in Treating Patients With Salivary Gland Cancer

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.
ClinicalTrials.gov Identifier: NCT00045669
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 12, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have unresectable and/or metastatic salivary gland cancer.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: imatinib mesylate Phase 2

Detailed Description:


  • Determine the antitumor activity of imatinib mesylate, in terms of objective response rates (partial and complete responses) and duration of overall response, in patients with unresectable and/or metastatic adenoid cystic, lymphoepithelioma-like, or myoepithelial salivary gland cancer.
  • Determine the safety and tolerability of this drug in these patients.
  • Correlate the activity of c-kit and downstream kinases in pre- and post-treatment tumoral biopsies with clinical course in patients treated with this drug.
  • Determine the effect of treatment with this drug on tumor samples from these patients in terms of proliferation, apoptosis, and angiogenesis.
  • Correlate the steady state levels of this drug achieved with clinical and laboratory correlative endpoints in these patients.
  • Determine whether early changes in metabolic activity correlate with molecular changes and predict outcome to therapy in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral imatinib mesylate twice daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with stable disease receive treatment for up to 6 months.

Patients are followed within 3 weeks and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 6-19 months.

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study Of Imatinib Mesylate In Adenoid Cystic, Lymphoepithelioma-Like And Myoepithelial Salivary Gland Carcinomas
Study Start Date : July 2002
Primary Completion Date : January 2004
Study Completion Date : January 2005

Information from the National Library of Medicine

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


  • Histologically or cytologically confirmed adenoid cystic, lymphoepithelioma-like, or myoepithelial salivary gland cancer

    • Unresectable AND/OR
    • Radiologically documented metastatic disease
  • c-kit positive tumor (1+, 2+, or 3+)
  • At least 1 unidimensionally measurable lesion

    • More than 20 mm by conventional techniques OR
    • More than 10 mm by spiral CT scan
  • No known brain metastases



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • More than 12 weeks


  • Absolute neutrophil count greater than 1,500/mm3
  • Platelet count greater than 100,000/mm3


  • Bilirubin less than 1.25 times upper limit of normal (ULN)
  • AST/ALT less than 2.5 times ULN


  • Creatinine less than 1.25 times ULN OR
  • Creatinine clearance greater than 50 mL/min


  • No myocardial infarction within the past 6 months
  • No congestive heart failure
  • No unstable angina
  • No active cardiomyopathy
  • No unstable ventricular arrhythmias
  • No uncontrolled hypertension


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 3 months after study
  • No other active malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or non-melanomatous skin cancer
  • No uncontrolled psychotic disorders
  • No serious infections
  • No active peptic ulcer disease
  • No other serious medical condition that would preclude study
  • No prior allergy to compounds of similar chemical or biologic composition as imatinib mesylate


Biologic therapy

  • No concurrent filgrastim (G-CSF)


  • At least 4 weeks since prior chemotherapy and recovered
  • No concurrent chemotherapy

Endocrine therapy

  • Not specified


  • At least 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy to sites of measurable disease


  • At least 4 weeks since prior surgery and recovered


  • No other concurrent investigational agents
  • No concurrent therapeutic warfarin

    • Mini-dose warfarin for prophylaxis or low-molecular weight heparin allowed
  • No concurrent erythromycin
  • No concurrent acetaminophen doses exceeding 3 g/day

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 ClinicalTrials.gov identifier (NCT number): NCT00045669

United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Evanston Northwestern Health Care - Evanston Hospital
Evanston, Illinois, United States, 60201
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
LaGrange Memorial Hospital
LaGrange, Illinois, United States, 60525
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, United States, 61602
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62701
United States, Indiana
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne, Indiana, United States, 46885-5099
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
United States, Michigan
Lakeland Medical Center - St. Joseph
Saint Joseph, Michigan, United States, 49085
United States, Missouri
Siteman Cancer Center
Saint Louis, Missouri, United States, 63110
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Canada, Ontario
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Sponsors and Collaborators
University Health Network, Toronto
National Cancer Institute (NCI)
Study Chair: George P. Browman, MD Margaret and Charles Juravinski Cancer Centre

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00045669     History of Changes
Other Study ID Numbers: CDR0000257029
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 12, 2012
Last Verified: June 2012

Keywords provided by University Health Network, Toronto:
recurrent salivary gland cancer
salivary gland adenoid cystic carcinoma
stage III salivary gland cancer
stage IV salivary gland cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Salivary Gland Neoplasms
Neoplasms by Site
Mouth Neoplasms
Mouth Diseases
Stomatognathic Diseases
Salivary Gland Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action