Spots Global Cancer Trial Database for Dasatinib in Treating Patients With Recurrent or Metastatic Malignant Salivary Gland Tumors
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Trial Identification
Brief Title: Dasatinib in Treating Patients With Recurrent or Metastatic Malignant Salivary Gland Tumors
Official Title: Phase II Trial of Dasatinib (BMS 354825) for Recurrent or Metastatic c-KIT Expressing Adenoid Cystic Carcinoma and Non-adenoid Cystic Malignant Salivary Tumors
Study ID: NCT00859937
Study Description
Brief Summary: This phase II trial is studying how well dasatinib works in treating patients with malignant salivary gland tumors that have come back after treatment or have spread to other parts of the body. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed Description: PRIMARY OBJECTIVES: I. Determine the objective response rate (complete response plus partial response) of dasatinib in adenoid cystic carcinoma (ACC). II. Determine the progression-free survival of dasatinib in ACC. SECONDARY OBJECTIVES: I. Determine the duration of response. II. Determine the stable disease rate and duration of stable disease. III. Determine progression-free survival. IV. Determine the median survival. V. Determine the overall survival. VI. Determine the safety and tolerability. TERTIARY OBJECTIVES: I. To examine biomarkers that relate to SRC proto-oncogene, non-receptor tyrosine kinase (Src) signal transduction and to correlate these biomarkers with clinical response to dasatinib in ACC and non-ACC malignant salivary gland tumors (MSGT). II. Determine if activating mutations in platelet-derived growth factor alpha polypeptide (PDGFA) and KIT are associated with response in ACC. OUTLINE: Patients receive dasatinib orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed at 8 weeks.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Tower Cancer Research Foundation, Beverly Hills, California, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
Mercy UC Davis Cancer Center, Merced, California, United States
Moffitt Cancer Center, Tampa, Florida, United States
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital, Evanston, Illinois, United States
Ingalls Memorial Hospital, Harvey, Illinois, United States
Joliet Oncology-Hematology Associates Limited, Joliet, Illinois, United States
Loyola University Medical Center, Maywood, Illinois, United States
Illinois CancerCare-Peoria, Peoria, Illinois, United States
Central Illinois Hematology Oncology Center, Springfield, Illinois, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview, Fort Wayne, Indiana, United States
Northern Indiana Cancer Research Consortium, South Bend, Indiana, United States
University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Oncology Care Associates PLLC, Saint Joseph, Michigan, United States
Mercy Hospital Saint Louis, Saint Louis, Missouri, United States
Montefiore Medical Center-Wakefield Campus, Bronx, New York, United States
Montefiore Medical Center - Moses Campus, Bronx, New York, United States
Mount Sinai Hospital, New York, New York, United States
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States
M D Anderson Cancer Center, Houston, Texas, United States
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States
Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States
London Regional Cancer Program, London, Ontario, Canada
University Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada
CHUM-Hotel Dieu de Montreal, Montreal, Quebec, Canada
Contact Details
Name: Stuart Wong
Affiliation: University of Chicago Comprehensive Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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