Open-label Trial of GlivecĀ® (Imatinib Mesylate) in Patients With Primary or Recurrent Dermatofibrosarcoma Protuberans
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumor response at 6 and 12 weeks
Selma Ugurel, MD
Principal Investigator
Skin Cancer Unit, German Cancer Research Center Heidelberg and Department of Dermatology, University Hospital of Mannheim, Mannheim, Germany
Germany: Federal Institute for Drugs and Medical Devices
ADO/VOD DFSP 001
NCT00122473
January 2004
January 2007
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