Open-label Trial of Glivec® (Imatinib Mesylate) in Patients With Primary or Recurrent Dermatofibrosarcoma Protuberans
18 Years
N/A
Both
Dermatofibrosarcoma
Trial Information
Open-label Trial of Glivec® (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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Tumor response at 6 and 12 weeks
Principal Investigator
Selma Ugurel, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Skin Cancer Unit, German Cancer Research Center Heidelberg and Department of Dermatology, University Hospital of Mannheim, Mannheim, Germany
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
ADO/VOD DFSP 001
NCT ID:
NCT00122473
Start Date:
January 2004
Completion Date:
January 2007
Related Keywords:
- Dermatofibrosarcoma
- Dermatofibrosarcoma
- Imatinib
- Tyrosine Kinase Inhibitor
- Dermatofibrosarcoma
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