A Phase 2 interventional study of trastuzumab and laboratory biomarker analysis in High-grade Salivary Gland Mucoepidermoid Carcinoma, Recurrent Salivary Gland Cancer and Salivary Gland Acinic Cell Tumor, sponsored by National Cancer Institute (NCI). Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-28.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
This phase II trial is studying how well trastuzumab works in treating patients with metastatic or recurrent salivary gland cancer. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them
PRIMARY OBJECTIVES:
I. To assess response (confirmed and unconfirmed, complete and partial response) in patients with advanced high-grade salivary gland carcinoma treated with trastuzumab.
II. To assess one-year progression-free survival and one-year overall survival for patients treated with this regimen.
III. To assess the toxicities associated with this treatment regimen in this group of patients.
IV. To measure the indicators of C-erb B2 oncoprotein expression and C-erb B2 oncogene amplification and epidermal growth factor receptor expression and explore the relationship between these markers and response, progression-free survival and overall survival in preliminary fashion.
OUTLINE: Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 8 weeks until disease progression and then every 3 months for 1 year and every 6 months until 3 years from study entry.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 35 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Biological: trastuzumab · Other: laboratory biomarker analysis
Given IV
Also known as: anti-c-erB-2, Herceptin, MOAB HER2
Correlative studies
Response (confirmed and unconfirmed, complete and partial response) in patients treated with trastuzumab
A true response probability of 30% or greater would be of interest.
Time frame: Up to 4 years
Progression-free survival
Time frame: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 1 year
Overall survival
Time frame: Up to 4 years
This study is terminated, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)