Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00104949
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2005-03-03
Brief Title:
Trastuzumab in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma
Sponsor:
SWOG Cancer Research Network
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Trastuzumab NSC-688097 in Treatment of Locally Advanced or Metastatic Synovial Sarcoma
Status:
COMPLETED
Status Verified Date:
2006-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
PURPOSE This phase II trial is studying how well trastuzumab works in treating patients with locally advanced or metastatic synovial sarcoma
Detailed Description:
OBJECTIVES
Primary
Determine the response rate confirmed complete response and partial response in patients with HER2neu-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 HER2neu 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
Primary
Determine the response rate confirmed complete response and partial response in patients with HER2neu-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 HER2neu 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SWOG-S0346 | None | None | None |