Recurrent Salivary Gland Carcinoma Clinical Trial
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
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.
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.
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