Imatinib Mesylate in Treating Patients With Salivary Gland Cancer

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ClinicalTrials.gov Identifier: NCT00045669

Recruitment Status : Completed

First Posted : January 27, 2003

Last Update Posted : February 15, 2019

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

University Health Network, Toronto

Study Description

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:

OBJECTIVES:

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	16 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
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
Actual Primary Completion Date :	January 2004
Actual Study Completion Date :	January 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adenoids

Drug Information available for: Imatinib Imatinib mesylate

Genetic and Rare Diseases Information Center resources: Adenoid Cystic Carcinoma Oral Cancer

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Imatinib Mesylate Adult patients with unresectable or metastatic adenoid cystic carcinoma measurable by Response Evaluation Criteria in Solid Tumors Group criteria and expressing c-kit by immunohistochemistry were treated with imatinib 400 mg orally bid. Response was assessed every 8 weeks	Drug: imatinib mesylate

Outcome Measures

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 120 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2

Life expectancy

More than 12 weeks

Hematopoietic

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

Hepatic

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

Renal

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

Cardiovascular

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

Other

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

No concurrent filgrastim (G-CSF)

Chemotherapy

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

Endocrine therapy

Not specified

Radiotherapy

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

Surgery

At least 4 weeks since prior surgery and recovered

Other

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

Contacts and Locations

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

Locations

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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)

Investigators

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Study Chair:	George P. Browman, MD	Margaret and Charles Juravinski Cancer Centre

More Information

Publications of Results:

Hotte SJ, Winquist EW, Lamont E, MacKenzie M, Vokes E, Chen EX, Brown S, Pond GR, Murgo A, Siu LL. Imatinib mesylate in patients with adenoid cystic cancers of the salivary glands expressing c-kit: a Princess Margaret Hospital phase II consortium study. J Clin Oncol. 2005 Jan 20;23(3):585-90.

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Responsible Party:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00045669
Other Study ID Numbers:	CDR0000257029 PMH-PHL-009 ( Other Identifier: Princess Margaret Cancer Centre ) NCI-5663 ( Other Grant/Funding Number: NCI )
First Posted:	January 27, 2003 Key Record Dates
Last Update Posted:	February 15, 2019
Last Verified:	February 2019

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:

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

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