Clinical Trial: Imatinib in Dermatofibrosarcoma Protuberans (DFSP)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Open-label Trial of Glivec® (Imatinib Mesylate) in Patients With Primary or Recurrent Dermatofibrosarcoma Protuberans
Brief Summary: The purpose of this study is to determine whether imatinib is effective in the treatment of primary and recurrent dermatofibrosarcoma protuberans (DFSP).
Detailed Summary: 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.
Sponsor: Dermatologic Cooperative Oncology Group
Current Primary Outcome: Tumor response at 6 and 12 weeks
Original Primary Outcome: Tumor response at 6 and 12 weeks.
Current Secondary Outcome:
- Rate of relapse within the first 2 years
- Association of tumor response with cytogenetic and receptor expression status
Original Secondary Outcome:
- Rate of relapse within the first 2 years.
- Association of tumor response with cytogenetic and receptor expression status.
Information By: Dermatologic Cooperative Oncology Group
Dates:
Date Received: July 20, 2005
Date Started: January 2004
Date Completion: January 2007
Last Updated: July 28, 2011
Last Verified: July 2011