Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| trastuzumab | Biological | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response rate (confirmed complete response and partial response)
Secondary outcomes (3)
- measure
- Progression-free survival at 1 and 2 years
- measure
- Overall survival at 1 and 2 years
- measure
- Toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 therapyReferences
Publications (0)
Data not yet available