Phase II Study of Trastuzumab (NSC-688097) in Treatment of Locally Advanced or Metastatic Synovial Sarcoma
- Determine the response rate (confirmed complete response and partial response) in
patients with HER2/neu-overexpressing locally advanced or metastatic synovial sarcoma
treated with trastuzumab (Herceptin^®).
- Determine the frequency and severity of toxic effects of this drug in these patients.
- Determine overall survival and progression-free survival of patients treated with this
- Correlate, preliminarily, SYT-SSX translocation, HER2/neu expression, and monophasic
and biphasic phenotype with clinical outcomes in patients treated with this drug.
OUTLINE: This is a pilot, multicenter study.
Patients receive trastuzumab (Herceptin^®) IV over 90 minutes on day 1. Courses repeat every
21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 weeks until disease
progression and then every 6 months for up to 2 years from study entry.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 10-40
Primary Purpose: Treatment
Response rate (confirmed complete response and partial response)
Ernest C. Borden, MD
The Cleveland Clinic
United States: Food and Drug Administration