A Phase 2 Study Of Imatinib Mesylate In Adenoid Cystic, Lymphoepithelioma-Like And Myoepithelial Salivary Gland Carcinomas
- 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
Masking: Open Label, Primary Purpose: Treatment
George P. Browman, MD
Margaret and Charles Juravinski Cancer Centre
United States: Federal Government
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Loyola University Medical Center||Maywood, Illinois 60153|
|Ingalls Memorial Hospital||Harvey, Illinois 60426|
|University of Wisconsin Comprehensive Cancer Center||Madison, Wisconsin 53792|
|CCOP - Northern Indiana CR Consortium||South Bend, Indiana 46601|
|Louis A. Weiss Memorial Hospital||Chicago, Illinois 60640|
|Fort Wayne Medical Oncology and Hematology, Incorporated||Fort Wayne, Indiana 46885-5099|
|Lakeland Medical Center - St. Joseph||Saint Joseph, Michigan 49085|
|Evanston Northwestern Health Care - Evanston Hospital||Evanston, Illinois 60201|
|Oncology/Hematology Associates of Central Illinois, P.C.||Peoria, Illinois 61602|
|Central Illinois Hematology Oncology Center||Springfield, Illinois 62701|
|Decatur Memorial Hospital Cancer Care Institute||Decatur, Illinois 62526|
|Siteman Cancer Center||Saint Louis, Missouri 63110|
|LaGrange Memorial Hospital||LaGrange, Illinois 60525|