Dasatinib in Treating Patients With Recurrent or Metastatic Malignant Salivary Gland Tumors (NCT00859937) | Clinical Trial Compass
CompletedPhase 2
Dasatinib in Treating Patients With Recurrent or Metastatic Malignant Salivary Gland Tumors
United States55 participantsStarted 2009-03-16
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically or cytologically confirmed malignant salivary gland tumor (MSGT), including one of the following histologic subtypes:
* Adenoid cystic carcinoma (ACC) with c v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog (Kit) overexpression or non-ACC MSGT that is not amenable to potentially curable surgery or radiation
* c-KIT overexpression in ACC patients is defined as cluster of differentiation (CD) 117 staining by immunohistochemistry (IHC) in 25% of tumor cells
* No stipulation for c-KIT overexpression is not required for non-ACC MSGT patients
* Patients must have radiographically measurable disease; radiographically measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral computed tomography (CT) scan
* Patients must have evidence of disease progression (objective growth of existing tumors) within 4 months of study entry
* No known brain metastases, unless patient meets both of the following criteria:
* Neurologic status stable for \>= 8 weeks after completion of definitive local therapy (surgery or radiotherapy)
* No neurologic dysfunction that would confound study results
* Life expectancy greater than 12 weeks
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2 OR Karnofsky performance status (PS) \>= 60%
* Leukocytes \>= 3,000/mcL
* Absolute…