Imatinib in Dermatofibrosarcoma Protuberans (DFSP)
キーワード
概要
説明
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.
日付
| 最終確認済み: | 06/30/2011 |
| 最初に提出された: | 07/19/2005 |
| 提出された推定登録数: | 07/20/2005 |
| 最初の投稿: | 07/21/2005 |
| 最終更新が送信されました: | 07/27/2011 |
| 最終更新日: | 07/28/2011 |
| 実際の研究開始日: | 12/31/2003 |
| 研究完了予定日: | 12/31/2006 |
状態または病気
介入/治療
Drug: Imatinib (Glivec)
段階
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
結果
主な結果の測定
1. Tumor response at 6 and 12 weeks [undefined]
二次的な結果の測定
1. Rate of relapse within the first 2 years [undefined]
2. Association of tumor response with cytogenetic and receptor expression status [undefined]
