Trastuzumab in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma
RATIONALE: 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. Trastuzumab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well trastuzumab works in treating patients with locally advanced or metastatic synovial sarcoma.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Study of Trastuzumab (NSC-688097) in Treatment of Locally Advanced or Metastatic Synovial Sarcoma|
- Response rate (confirmed complete response and partial response) [ Designated as safety issue: No ]
- Progression-free survival at 1 and 2 years [ Designated as safety issue: No ]
- Overall survival at 1 and 2 years [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
|Study Start Date:||July 2005|
|Study Completion Date:||August 2007|
- 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 drug.
- 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 months.
|Investigator:||Ernest C. Borden, MD||The Cleveland Clinic|
|Investigator:||Rashmi Chugh, MD||University of Michigan Cancer Center|
|Investigator:||George D. Demetri, MD||Dana-Farber Cancer Institute|
|Investigator:||Margaret von Mehren, MD||Fox Chase Cancer Center|
|Investigator:||Vivien H.C. Bramwell, MB, BS, PhD, FRCP||Tom Baker Cancer Centre - Calgary|
|Investigator:||Karen H. Albritton, MD||Dana-Farber Cancer Institute|