Status:
COMPLETED
Trastuzumab in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00104949
Start Date
July 1 2005
End Date
August 1 2007
Last Update
June 24 2013
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