Trastuzumab in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00104949|
Recruitment Status : Completed
First Posted : March 4, 2005
Last Update Posted : June 24, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Biological: trastuzumab||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Official Title:||Phase II Study of Trastuzumab (NSC-688097) in Treatment of Locally Advanced or Metastatic Synovial Sarcoma|
|Study Start Date :||July 2005|
|Actual Study Completion Date :||August 2007|
- Response rate (confirmed complete response and partial response)
- Progression-free survival at 1 and 2 years
- Overall survival at 1 and 2 years
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00104949
|OverallOfficial:||Ernest C. Borden, MD||The Cleveland Clinic|
|OverallOfficial:||Rashmi Chugh, MD||University of Michigan Cancer Center|
|OverallOfficial:||George D. Demetri, MD||Dana-Farber Cancer Institute|
|OverallOfficial:||Margaret von Mehren, MD||Fox Chase Cancer Center|
|OverallOfficial:||Vivien H.C. Bramwell, MB, BS, PhD, FRCP||Tom Baker Cancer Centre - Calgary|
|OverallOfficial:||Karen H. Albritton, MD||Dana-Farber Cancer Institute|