Trastuzumab in Treating Patients With Locally Advanced or Metastatic Synovial Sarcoma

NCT00104949 | Completed Phase 2

• 2 other identifiers: CDR0000413703SWOG-S0346
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sarcoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Response rate (confirmed complete response and partial response)

Secondary Outcomes (3)

• Progression-free survival at 1 and 2 years

• Overall survival at 1 and 2 years

• Toxicity

Interventions

trastuzumab BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Sarcoma; Sarcoma, Synovial

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Connective Tissue

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• 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 Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: March 3, 2005
• First Posted: March 4, 2005
• Study Start: July 1, 2005
• Study Completion: August 1, 2007
• Last Updated: June 24, 2013

Record last verified: 2006-12