Clinical Trial: Trastuzumab in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase II Study of Trastuzumab (NSC-688097) in Treatment of Locally Advanced or Metastatic Synovial Sarcoma

Brief Summary:

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.


Detailed Summary:

OBJECTIVES:

Primary

  • 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^®).

Secondary

  • 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.


Sponsor: Southwest Oncology Group

Current Primary Outcome: Response rate (confirmed complete response and partial response)

Original Primary Outcome:

Current Secondary Outcome:

  • Progression-free survival at 1 and 2 years
  • Overall survival at 1 and 2 years
  • Toxicity


Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: March 3, 2005
Date Started: July 2005
Date Completion:
Last Updated: June 21, 2013
Last Verified: December 2006