Sarcoma Clinical Trial
Official title:
Phase II Study of Recombinant Humanized Monoclonal Antibody Against HER2 for the Treatment of Recurrent Osteosarcoma
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.
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.
;
Primary Purpose: Treatment
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