Open-label Trial of Glivec® (Imatinib Mesylate) in Patients With Primary or Recurrent Dermatofibrosarcoma Protuberans
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 8
- 主要终点
- Tumor response at 6 and 12 weeks
研究概览
简要总结
The purpose of this study is to determine whether imatinib is effective in the treatment of primary and recurrent dermatofibrosarcoma protuberans (DFSP).
详细描述
This study is aimed to investigate the efficacy of imatinib (Glivec) in the treatment of primary and locally relapsed dermatofibrosarcoma protuberans (DFSP). DFSP is a cutaneous neoplasm well known for its overexpression of the platelet-derived growth factor (PDGF). Herein, imatinib provides a systemic treatment option that offers the possibility of a reduction of the wide surgical margins used today in surgery of primary DFSP, or even of a complete avoidance of surgical treatment in this disease. Since imatinib exerts its function via interference with protein tyrosine kinase activities, it inhibits the platelet-derived growth factor receptor (PDGF-R) signaling cascade that plays a crucial role in the pathogenesis and tumor growth of DFSP. Since imatinib has been shown to shrink metastatic lesions of DFSP, there is a strong rationale to expect that it also decreases cell proliferation and tumor growth in primary DFSP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosis of primary or recurrent dermatofibrosarcoma protuberans
- •Measurable tumor parameters (by magnetic resonance imaging [MRI])
- •Patient >/= 18 years of age
- •ECOG performance status < 3
- •Adequate organ function
- •Patients must be able to swallow capsules
- •Female patients of childbearing potential must have negative pregnancy test
- •Written, voluntary, informed consent; must include investigational use of tumor tissue biopsies.
排除标准
- •Any evidence of distant metastases
- •Patient has received any other investigational agents within 28 days of first day of study drug dosing
- •Patient is < 5 years free of another primary malignancy except basal cell skin cancer or cervical carcinoma in situ
- •Grade III/IV cardiac problems as defined by the New York Heart Association
- •Severe and/or uncontrolled medical disease
- •Known diagnosis of human immunodeficiency virus (HIV) infection
结局指标
主要结局
Tumor response at 6 and 12 weeks
次要结局
- Rate of relapse within the first 2 years
- Association of tumor response with cytogenetic and receptor expression status