NCT00045669
Imatinib Mesylate in Treating Patients With Salivary Gland Cancer
PHASE2
COMPLETED
NCT00045669
INTERVENTIONAL
A Phase 2 Study Of Imatinib Mesylate In Adenoid Cystic, Lymphoepithelioma-Like And Myoepithelial Salivary Gland Carcinomas
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.
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
Head and Neck Cancer
- TREATMENT
-
- Type: DRUG
- Name: imatinib mesylate
- Description:
- Arm Group Labels: Imatinib Mesylate
- University Health Network, Toronto