Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-01 @ 2:57 PM
Study NCT ID:
NCT00045669
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2002-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Imatinib Mesylate in Treating Patients With Salivary Gland Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D012468', 'term': 'Salivary Gland Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009062', 'term': 'Mouth Neoplasms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068877', 'term': 'Imatinib Mesylate'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-13', 'studyFirstSubmitDate': '2002-09-06', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-01', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['recurrent salivary gland cancer', 'salivary gland adenoid cystic carcinoma', 'stage III salivary gland cancer', 'stage IV salivary gland cancer'], 'conditions': ['Head and Neck Cancer']}, 'referencesModule': {'references': [{'pmid': '15659505', 'type': 'RESULT', 'citation': 'Hotte 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.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.\n\nPURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have unresectable and/or metastatic salivary gland cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* 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.\n* Determine the safety and tolerability of this drug in these patients.\n* 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.\n* Determine the effect of treatment with this drug on tumor samples from these patients in terms of proliferation, apoptosis, and angiogenesis.\n* Correlate the steady state levels of this drug achieved with clinical and laboratory correlative endpoints in these patients.\n* Determine whether early changes in metabolic activity correlate with molecular changes and predict outcome to therapy in these patients.\n\nOUTLINE: This is a multicenter study.\n\nPatients 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.\n\nPatients are followed within 3 weeks and then every 3 months thereafter.\n\nPROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 6-19 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed adenoid cystic, lymphoepithelioma-like, or myoepithelial salivary gland cancer\n\n * Unresectable AND/OR\n * Radiologically documented metastatic disease\n* c-kit positive tumor (1+, 2+, or 3+)\n* At least 1 unidimensionally measurable lesion\n\n * More than 20 mm by conventional techniques OR\n * More than 10 mm by spiral CT scan\n* No known brain metastases\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* More than 12 weeks\n\nHematopoietic\n\n* Absolute neutrophil count greater than 1,500/mm3\n* Platelet count greater than 100,000/mm3\n\nHepatic\n\n* Bilirubin less than 1.25 times upper limit of normal (ULN)\n* AST/ALT less than 2.5 times ULN\n\nRenal\n\n* Creatinine less than 1.25 times ULN OR\n* Creatinine clearance greater than 50 mL/min\n\nCardiovascular\n\n* No myocardial infarction within the past 6 months\n* No congestive heart failure\n* No unstable angina\n* No active cardiomyopathy\n* No unstable ventricular arrhythmias\n* No uncontrolled hypertension\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective barrier contraception during and for 3 months after study\n* No other active malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or non-melanomatous skin cancer\n* No uncontrolled psychotic disorders\n* No serious infections\n* No active peptic ulcer disease\n* No other serious medical condition that would preclude study\n* No prior allergy to compounds of similar chemical or biologic composition as imatinib mesylate\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No concurrent filgrastim (G-CSF)\n\nChemotherapy\n\n* At least 4 weeks since prior chemotherapy and recovered\n* No concurrent chemotherapy\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* At least 4 weeks since prior radiotherapy and recovered\n* No concurrent radiotherapy to sites of measurable disease\n\nSurgery\n\n* At least 4 weeks since prior surgery and recovered\n\nOther\n\n* No other concurrent investigational agents\n* No concurrent therapeutic warfarin\n\n * Mini-dose warfarin for prophylaxis or low-molecular weight heparin allowed\n* No concurrent erythromycin\n* No concurrent acetaminophen doses exceeding 3 g/day'}, 'identificationModule': {'nctId': 'NCT00045669', 'briefTitle': 'Imatinib Mesylate in Treating Patients With Salivary Gland Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'A Phase 2 Study Of Imatinib Mesylate In Adenoid Cystic, Lymphoepithelioma-Like And Myoepithelial Salivary Gland Carcinomas', 'orgStudyIdInfo': {'id': 'CDR0000257029'}, 'secondaryIdInfos': [{'id': 'PMH-PHL-009', 'type': 'OTHER', 'domain': 'Princess Margaret Cancer Centre'}, {'id': 'NCI-5663', 'type': 'OTHER_GRANT', 'domain': 'NCI'}]}, 'armsInterventionsModule': {'armGroups': [{'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']}], 'interventions': [{'name': 'imatinib mesylate', 'type': 'DRUG', 'armGroupLabels': ['Imatinib Mesylate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637-1470', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Cancer Research Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60640', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Louis A. Weiss Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '62526', 'city': 'Decatur', 'state': 'Illinois', 'country': 'United States', 'facility': 'Decatur Memorial Hospital Cancer Care Institute', 'geoPoint': {'lat': 39.84031, 'lon': -88.9548}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Evanston Northwestern Health Care - Evanston Hospital', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '60426', 'city': 'Harvey', 'state': 'Illinois', 'country': 'United States', 'facility': 'Ingalls Memorial Hospital', 'geoPoint': {'lat': 41.61003, 'lon': -87.64671}}, {'zip': '60525', 'city': 'LaGrange', 'state': 'Illinois', 'country': 'United States', 'facility': 'LaGrange Memorial Hospital', 'geoPoint': {'lat': 41.80568, 'lon': -87.86942}}, {'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'Loyola University Medical Center', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '61602', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Oncology/Hematology Associates of Central Illinois, P.C.', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '62701', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Central Illinois Hematology Oncology Center', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '46885-5099', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Fort Wayne Medical Oncology and Hematology, Incorporated', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '46601', 'city': 'South Bend', 'state': 'Indiana', 'country': 'United States', 'facility': 'CCOP - Northern Indiana CR Consortium', 'geoPoint': {'lat': 41.68338, 'lon': -86.25001}}, {'zip': '49085', 'city': 'Saint Joseph', 'state': 'Michigan', 'country': 'United States', 'facility': 'Lakeland Medical Center - St. Joseph', 'geoPoint': {'lat': 42.10976, 'lon': -86.48002}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Siteman Cancer Center', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '53792-6164', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Comprehensive Cancer Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': 'L8V 5C2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Cancer Care Ontario-Hamilton Regional Cancer Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'George P. Browman, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Margaret and Charles Juravinski Cancer Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}