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| Sponsor: | University of Chicago |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00859937 |
Purpose
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with recurrent or metastatic malignant salivary gland tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Drug: dasatinib Genetic: gene expression analysis Genetic: gene rearrangement analysis Genetic: mutation analysis Genetic: polymerase chain reaction Genetic: polymorphism analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: pharmacogenomic studies |
Phase II |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Estimated Enrollment: | 65 |
| Study Start Date: | March 2009 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 cohorts according to histologic subtype (adenoid cystic carcinoma [ACC] vs non-ACC).
Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blood and tumor tissue samples are collected at baseline for correlative laboratory biomarker and pharmacogenomic studies. Samples are analyzed for total c-Src and phosphorylated Src expression by IHC; polymorphisms and gene rearrangements/activating mutations in PDGFA (within exons 18 and 12) and KIT (within exons 9, 11, 13, and 27) by PCR; and additional biomarkers associated with Src signal transduction and/or dasatinib response (e.g., phospho-KIT, phospho-PDGFR, EPHA2, VEGF, Stat3, Bcl-x, survivin, cyclin D1, and p27_Kip) by IHC.
After completion of study therapy, patients are followed for at least 8 weeks.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed malignant salivary gland tumor, including one of the following histologic subtypes:
Adenoid cystic carcinoma (ACC)
Non-ACC
No known brain metastases, unless patient meets both of the following criteria:
PATIENT CHARACTERISTICS:
None of the following conditions:
No concurrent uncontrolled illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Recruiting |
| Tampa, Florida, United States, 33612-9497 | |
| Contact: Clinical Trials Office - H. Lee Moffitt Cancer Center and Rese 800-456-7121 canceranswers@moffitt.org | |
| United States, Georgia | |
| Winship Cancer Institute of Emory University | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Nabil Saba, MD 404-686-3496 | |
| United States, Illinois | |
| University of Chicago Cancer Research Center | Recruiting |
| Chicago, Illinois, United States, 60637-1470 | |
| Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424 | |
| Decatur Memorial Hospital Cancer Care Institute | Recruiting |
| Decatur, Illinois, United States, 62526 | |
| Contact: Clinical Trials Office - Decatur Memorial Hospital Cancer Care 217-876-4750 | |
| Evanston Hospital | Recruiting |
| Evanston, Illinois, United States, 60201-1781 | |
| Contact: Clinical Trials Office - Evanston Hospital 847-570-1381 | |
| Ingalls Cancer Care Center at Ingalls Memorial Hospital | Recruiting |
| Harvey, Illinois, United States, 60426 | |
| Contact: Clinical Trials Office - Ingalls Cancer Care Center at Ingalls 708-915-4673 | |
| Joliet Oncology-Hematology Associates, Limited - West | Recruiting |
| Joliet, Illinois, United States, 60435 | |
| Contact: Sanjiv S. Modi, MD 815-730-3098 smod@jolietoncology.com | |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Recruiting |
| Maywood, Illinois, United States, 60153 | |
| Contact: Clinical Trials Office - Cardinal Bernardin Cancer Center 708-226-4357 | |
| Oncology Hematology Associates of Central Illinois, PC - Peoria | Recruiting |
| Peoria, Illinois, United States, 61615-7828 | |
| Contact: Sachdev P. Thomas, MD 309-243-1000 sthomas@ohaci.com | |
| Central Illinois Hematology Oncology Center | Recruiting |
| Springfield, Illinois, United States, 62701 | |
| Contact: Edem S. Agamah, MD, MS 217-525-2500 ihdn@aol.com | |
| United States, Indiana | |
| Fort Wayne Medical Oncology and Hematology | Recruiting |
| Fort Wayne, Indiana, United States, 46885-5099 | |
| Contact: Sreenivasa R. Nattam, MD 260-484-8830 ledgar@fwmoh.com | |
| CCOP - Northern Indiana CR Consortium | Recruiting |
| South Bend, Indiana, United States, 46601 | |
| Contact: David A. Taber, MD 574-647-3353 | |
| United States, Maryland | |
| Greenebaum Cancer Center at University of Maryland Medical Center | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Clinical Trials Office - Greenebaum Cancer Center at Universit 800-888-8823 | |
| United States, Michigan | |
| University of Michigan Comprehensive Cancer Center | Recruiting |
| Ann Arbor, Michigan, United States, 48109-0942 | |
| Contact: Clinical Trials Office - University of Michigan Comprehensive 800-865-1125 | |
| Oncology Care Associates, PLLC | Recruiting |
| Saint Joseph, Michigan, United States, 49085 | |
| Contact: Eric P. Lester, MD 269-985-0029 | |
| United States, Missouri | |
| David C. Pratt Cancer Center at St. John's Mercy | Recruiting |
| Saint Louis, Missouri, United States, 63141 | |
| Contact: Clinical Trials Office - David C. Pratt Cancer Center at St. J 314-251-6770 | |
| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center | Recruiting |
| Nashville, Tennessee, United States, 37232-6307 | |
| Contact: Jill Gilbert, MD Not Available | |
| United States, Virginia | |
| Virginia Commonwealth University Massey Cancer Center | Recruiting |
| Richmond, Virginia, United States, 23298-0037 | |
| Contact: Clinical Trials Office -Virginia Commonwealth University Masse 804-628-1939 | |
| Canada, Ontario | |
| London Regional Cancer Program at London Health Sciences Centre | Recruiting |
| London, Ontario, Canada, N6A 4L6 | |
| Contact: Eric Winquist, MD 519-685-8500 ext. 58640 | |
| Princess Margaret Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Contact: Lillian L. Siu, MD, FRCPC 416-946-2911 | |
| Canada, Quebec | |
| CHUM - Hotel Dieu Hospital | Recruiting |
| Montreal, Quebec, Canada, H2L-4M1 | |
| Contact: Denis Soulieres, MD, MSC 514-890-8200 ext. 27066 denis.soulieres.chum@ssss.gouv.qc.ca | |
| Study Chair: | Stuart J. Wong, MD | Medical College of Wisconsin |
More Information
| Responsible Party: | Everett E. Vokes, University of Chicago Cancer Research Center |
| ClinicalTrials.gov Identifier: | NCT00859937 History of Changes |
| Other Study ID Numbers: | CDR0000636685, UCCRC-16691B |
| Study First Received: | March 10, 2009 |
| Last Updated: | February 22, 2011 |
| Health Authority: | Unspecified |
|
stage IV salivary gland cancer recurrent salivary gland cancer salivary gland adenoid cystic carcinoma high-grade salivary gland mucoepidermoid carcinoma salivary gland adenocarcinoma salivary gland anaplastic carcinoma |
salivary gland malignant mixed cell type tumor salivary gland poorly differentiated carcinoma salivary gland squamous cell carcinoma low-grade salivary gland mucoepidermoid carcinoma salivary gland acinic cell tumor |
|
Carcinoma, Adenoid Cystic Head and Neck Neoplasms Salivary Gland Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms by Site |
Mouth Neoplasms Mouth Diseases Stomatognathic Diseases Salivary Gland Diseases Dasatinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |