Trastuzumab in Treating Patients With Recurrent Osteosarcoma

Study Overview
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Brief Summary
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RATIONALE: Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of trastuzumab in treating patients who have recurrent osteosarcoma.

Detailed Description
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OBJECTIVES: Determine the response rate, freedom from progression, and survival of patients with recurrent osteosarcoma when treated with trastuzumab (Herceptin). Evaluate the toxicity of this drug in young patients with a history of osteosarcoma and prior therapy with doxorubicin. OUTLINE: This is a multicenter study. Patients receive trastuzumab (Herceptin) IV over 30-90 minutes weekly. Treatment continues for up to 52 weeks in the absence of disease progression or unacceptable toxicity. After approximately 12 weeks of treatment, patients are evaluated for response and undergo surgical resection if clinically appropriate. Patients are followed for 1 year for survival. PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study within 2 years.

Official Title
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Phase II Study of Recombinant Humanized Monoclonal Antibody Against HER2 for the Treatment of Recurrent Osteosarcoma

Conditions
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Sarcoma

Intervention / Treatment
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* Biological: trastuzumab
* Procedure: conventional surgery


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed recurrent osteosarcoma after initial systemic therapy with doxorubicin Measurable disease Immunohistochemical evidence of 2+ overexpression of HER2 PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 80-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: ALT or AST less than 3 times upper limit of normal (ULN) Bilirubin less than 1.5 times ULN Renal: Creatinine less than 1.5 times ULN OR Creatinine clearance greater than 60 mL/min Cardiovascular: Fractional shortening at least 29% by echocardiogram OR Ejection fraction at least 50% by MUGA No prior cardiac dysfunction, even if presently controlled Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy No prior anthracycline more than 450 mg/m^2 Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No other concurrent cancer therapy
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: trastuzumab|nan|
|Procedure: conventional surgery|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent osteosarcoma