Imatinib Mesylate in Treating Patients With Salivary Gland Cancer
- Registration Number
- NCT00045669
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Imatinib Mesylate 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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
Oncology/Hematology Associates of Central Illinois, P.C.
🇺🇸Peoria, Illinois, United States
LaGrange Memorial Hospital
🇺🇸LaGrange, Illinois, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Central Illinois Hematology Oncology Center
🇺🇸Springfield, Illinois, United States
Siteman Cancer Center
🇺🇸Saint Louis, Missouri, United States
Louis A. Weiss Memorial Hospital
🇺🇸Chicago, Illinois, United States
Evanston Northwestern Health Care - Evanston Hospital
🇺🇸Evanston, Illinois, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Incorporated
🇺🇸Fort Wayne, Indiana, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Decatur Memorial Hospital Cancer Care Institute
🇺🇸Decatur, Illinois, United States
Ingalls Memorial Hospital
🇺🇸Harvey, Illinois, United States
Cancer Care Ontario-Hamilton Regional Cancer Centre
🇨🇦Hamilton, Ontario, Canada
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
Lakeland Medical Center - St. Joseph
🇺🇸Saint Joseph, Michigan, United States