Study of Imatinib (Glivec) in Patients With Adenoid Cystic Carcinoma of the Head and Neck
Cancer of the Head and Neck, Carcinoma, Adenoid Cystic
About this trial
This is an interventional treatment trial for Cancer of the Head and Neck focused on measuring Adenoid cystic carcinoma of the head and neck
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically proven adenoid cystic carcinoma overexpressing KIT (by immunohistochemistry) with recurrent disease documented by computed tomography (CT) scan or magnetic resonance imaging (MRI). Presence of at least one dimensionally measurable target lesion (contrast enhancing lesion with the largest diameter >= 2 cm, based on CT or MRI scan done within 4 weeks before the start of treatment). Patients able to swallow an oral compound. World Health Organization (WHO) performance status < 2. Life expectancy of >= 3 months. Aged >= 18 years. Normal hematological (neutrophils >= 1.5 x 10^9 cells/l, platelets >= 100 x 10^9 cells/l), hepatic (bilirubin < 1.5 times the upper limit of the normal range; alkaline phosphatase and transaminases <= 2.5 x the upper limit of the normal range) and renal (serum creatinine <= 150 mmol/l) functions. Written informed consent. Exclusion Criteria: Abnormal cardiac function with history of ischaemic heart disease in the past 6 months and/or abnormal 12 lead electrocardiogram (ECG). Previous or current malignancies at other sites with the exception of cone biopsied carcinoma of the cervix and adequately treated basal or squamous cell skin carcinoma. Concomitant treatment with warfarin or any other anticoagulants. Unstable systemic diseases or active uncontrolled infections. Patients (male and female) not using effective contraception if of reproductive potential. Females pregnant or lactating or positive beta human chorionic gonadotropin (bHCG) at baseline
Sites / Locations
- Institut Gustave RoussyRecruiting