Spots Global Cancer Trial Database for Imatinib Mesylate in Treating Patients With Salivary Gland Cancer
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Trial Identification
Brief Title: Imatinib Mesylate in Treating Patients With Salivary Gland Cancer
Official Title: A Phase 2 Study Of Imatinib Mesylate In Adenoid Cystic, Lymphoepithelioma-Like And Myoepithelial Salivary Gland Carcinomas
Study ID: NCT00045669
Conditions
Interventions
Study Description
Brief Summary: 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: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Louis A. Weiss Memorial Hospital, Chicago, Illinois, United States
Decatur Memorial Hospital Cancer Care Institute, Decatur, Illinois, United States
Evanston Northwestern Health Care - Evanston Hospital, Evanston, Illinois, United States
Ingalls Memorial Hospital, Harvey, Illinois, United States
LaGrange Memorial Hospital, LaGrange, Illinois, United States
Loyola University Medical Center, Maywood, Illinois, United States
Oncology/Hematology Associates of Central Illinois, P.C., Peoria, Illinois, United States
Central Illinois Hematology Oncology Center, Springfield, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Incorporated, Fort Wayne, Indiana, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States
Lakeland Medical Center - St. Joseph, Saint Joseph, Michigan, United States
Siteman Cancer Center, Saint Louis, Missouri, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States
Cancer Care Ontario-Hamilton Regional Cancer Centre, Hamilton, Ontario, Canada
Contact Details
Name: George P. Browman, MD
Affiliation: Margaret and Charles Juravinski Cancer Centre
Role: STUDY_CHAIR
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