NCT00005033已完成2 期
Phase II Study of Recombinant Humanized Monoclonal Antibody Against HER2 for the Treatment of Recurrent Osteosarcoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 4
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed recurrent osteosarcoma after initial systemic therapy with doxorubicin
- •Measurable disease
- •Immunohistochemical evidence of 2+ overexpression of HER2
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Karnofsky 80-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •ALT or AST less than 3 times upper limit of normal (ULN)
- •Bilirubin less than 1.5 times ULN
- •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
- •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
- •Not specified
- •No other concurrent cancer therapy
排除标准
- 未提供
研究者
研究点 (4)
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