A Phase 2 interventional study of trastuzumab in Sarcoma, sponsored by SWOG Cancer Research Network. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-24.
Sponsored by SWOG Cancer Research Network · Phase 2, Interventional, and Treatment
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.
OBJECTIVES:
Primary
Secondary
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.
1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.
This study's planned enrollment of 40 is close to the median of 40 across 1,283 interventional studies indexed under Sarcoma.
Browse Sarcoma studies →SWOG Cancer Research Network is the lead sponsor of 328 studies on the registry; 37 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed synovial sarcoma meeting 1 of the following stage criteria:
Locally advanced disease, defined as 1 of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Response rate (confirmed complete response and partial response)
Progression-free survival at 1 and 2 years
Overall survival at 1 and 2 years
Toxicity
No study locations are listed for this record.
This study is completed, as verified in Dec 2006. You cannot join it, but the record below documents what was studied.
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SWOG Cancer Research Network