Clinical trial · Interventional
Imatinib Mesylate in Treating Patients With Salivary Gland Cancer
A Phase 2 Study Of Imatinib Mesylate In Adenoid Cystic, Lymphoepithelioma-Like And Myoepithelial Salivary Gland Carcinomas
NCT00045669CI-TRIAL-00037086completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Imatinib Mesylate
- description
- 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
- interventionNames
- Drug: imatinib mesylate
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTHotte SJ, Winquist EW, Lamont E, MacKenzie M, Vokes E, Chen EX, Brown S, Pond GR, Murgo A, Siu LL. Imatinib mesylate in patients with adenoid cystic cancers of the salivary glands expressing c-kit: a Princess Margaret Hospital phase II consortium study. J Clin Oncol. 2005 Jan 20;23(3):585-90. doi: 10.1200/JCO.2005.06.125. PMID 15659505