- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00104949
Trastuzumab in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma
Phase II Study of Trastuzumab (NSC-688097) in Treatment of 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 Overview
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically confirmed synovial sarcoma meeting 1 of the following stage criteria:
Locally advanced disease, defined as 1 of the following:
- Incurable by conventional multidisciplinary therapy, including surgery
- Surgically resectable only with significant morbidity
- Metastatic disease
- Tumor HER2/neu positive (2+ or 3+) by immunohistochemistry
- Tumor tissue must be available AND patient must be willing to allow specimen submission
- Measurable disease
- No known CNS metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count > 1,000/mm^3
- Hemoglobin > 8 g/dL
- Platelet count > 100,000/mm^3
Hepatic
- Bilirubin < 1.5 times upper limit of normal (ULN)
- SGOT and/or SGPT < 1.5 times ULN (5 times ULN if liver metastases are present)
Renal
- Creatinine < 1.5 times ULN OR
- Creatinine clearance > 60 mL/min
Cardiovascular
- LVEF > 45% by MUGA
Gastrointestinal
- No active peptic ulcer disease
- No active gastrointestinal bleeding
- No active inflammatory bowel disease
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No known HIV positivity
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent filgrastim (G-CSF)
Chemotherapy
- At least 3 weeks since prior chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- At least 60 days since prior radiotherapy to the target lesion*
- No concurrent radiotherapy NOTE: *Lesion must have demonstrated disease progression after completion of therapy
Surgery
- At least 21 days since prior major surgery and recovered
Other
- At least 60 days since prior embolization or radiofrequency ablation to the target lesion* NOTE: *Lesion must have demonstrated disease progression after completion of therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Response rate (confirmed complete response and partial response)
|
Secondary Outcome Measures
Outcome Measure |
---|
Toxicity
|
Progression-free survival at 1 and 2 years
|
Overall survival at 1 and 2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Ernest C. Borden, MD, The Cleveland Clinic
- Rashmi Chugh, MD, University of Michigan Rogel Cancer Center
- George D. Demetri, MD, Dana-Farber Cancer Institute
- Margaret von Mehren, MD, Fox Chase Cancer Center
- Vivien H.C. Bramwell, MB, BS, PhD, FRCP, Tom Baker Cancer Centre - Calgary
- Karen H. Albritton, MD, Dana-Farber Cancer Institute
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000413703
- SWOG-S0346
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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