Imatinib Mesylate in Treating Patients With Salivary Gland Cancer
Head and Neck Cancer
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring recurrent salivary gland cancer, salivary gland adenoid cystic carcinoma, stage III salivary gland cancer, stage IV salivary gland cancer
Eligibility 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
Sites / Locations
- University of Chicago Cancer Research Center
- Louis A. Weiss Memorial Hospital
- Decatur Memorial Hospital Cancer Care Institute
- Evanston Northwestern Health Care - Evanston Hospital
- Ingalls Memorial Hospital
- LaGrange Memorial Hospital
- Loyola University Medical Center
- Oncology/Hematology Associates of Central Illinois, P.C.
- Central Illinois Hematology Oncology Center
- Fort Wayne Medical Oncology and Hematology, Incorporated
- CCOP - Northern Indiana CR Consortium
- Lakeland Medical Center - St. Joseph
- Siteman Cancer Center
- University of Wisconsin Comprehensive Cancer Center
- Cancer Care Ontario-Hamilton Regional Cancer Centre
Arms of the Study
Arm 1
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