Trastuzumab in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

trastuzumab

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring adult synovial sarcoma, recurrent adult soft tissue sarcoma, stage III adult soft tissue sarcoma, stage IV adult soft tissue sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Response rate (confirmed complete response and partial response)

Secondary Outcome Measures

Progression-free survival at 1 and 2 years

Overall survival at 1 and 2 years

Toxicity

Full Information

NCT ID

NCT00104949

First Posted

March 3, 2005

Last Updated

June 21, 2013

Sponsor

SWOG Cancer Research Network

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00104949

Brief Title

Trastuzumab in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma

Official Title

Phase II Study of Trastuzumab (NSC-688097) in Treatment of Locally Advanced or Metastatic Synovial Sarcoma

Study Type

Interventional

2. Study Status

Record Verification Date

December 2006

Overall Recruitment Status

Completed

Study Start Date

July 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

SWOG Cancer Research Network

Collaborators

National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sarcoma

Keywords

adult synovial sarcoma, recurrent adult soft tissue sarcoma, stage III adult soft tissue sarcoma, stage IV adult soft tissue sarcoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

trastuzumab

Primary Outcome Measure Information:

Title

Response rate (confirmed complete response and partial response)

Secondary Outcome Measure Information:

Title

Progression-free survival at 1 and 2 years

Title

Overall survival at 1 and 2 years

Title

Toxicity

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials: