Imatinib Mesylate in Treating Patients With Salivary Gland Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase 2 Study Of Imatinib Mesylate In Adenoid Cystic, Lymphoepithelioma-Like And Myoepithelial Salivary Gland Carcinomas

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Drug: imatinib mesylate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Imatinib Mesylate<br>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 | Drug: imatinib mesylate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent salivary gland cancer, salivary gland adenoid cystic carcinoma, stage III salivary gland cancer, stage IV salivary gland cancer