Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT00045669
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00045669
Study Brief:
Protocol Section:
NCT00045669