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Imatinib in Dermatofibrosarcoma Protuberans (DFSP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00122473
Recruitment Status : Completed
First Posted : July 22, 2005
Last Update Posted : July 29, 2011
Information provided by:
Dermatologic Cooperative Oncology Group

Brief Summary:
The purpose of this study is to determine whether imatinib is effective in the treatment of primary and recurrent dermatofibrosarcoma protuberans (DFSP).

Condition or disease Intervention/treatment Phase
Dermatofibrosarcoma Drug: Imatinib (Glivec) Phase 1 Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label Trial of Glivec® (Imatinib Mesylate) in Patients With Primary or Recurrent Dermatofibrosarcoma Protuberans
Study Start Date : January 2004
Study Completion Date : January 2007

Primary Outcome Measures :
  1. Tumor response at 6 and 12 weeks

Secondary Outcome Measures :
  1. Rate of relapse within the first 2 years
  2. Association of tumor response with cytogenetic and receptor expression status

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00122473

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Skin Cancer Unit, German Cancer Research Center and Department of Dermatology, University Hospital of Mannheim
Mannheim, Baden-Württemberg, Germany, 68167
Department of Dermatology, ElbeKliniken - Klinikum Buxtehude
Buxtehude, Niedersachsen, Germany, 21614
Department of Dermatology, The Saarland University Hospital
Homburg/Saar, Saarland, Germany, 66424
Department of Dermatology, Martin-Luther-University Halle-Wittenberg
Halle/Saale, Sachsen-Anhalt, Germany, 06097
Sponsors and Collaborators
Dermatologic Cooperative Oncology Group
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Principal Investigator: Selma Ugurel, MD Skin Cancer Unit, German Cancer Research Center Heidelberg and Department of Dermatology, University Hospital of Mannheim, Mannheim, Germany
Principal Investigator: Dirk Schadendorf, MD Skin Cancer Unit, German Cancer Research Center Heidelberg and Department of Dermatology, University Hospital of Mannheim, Mannheim, Germany

Layout table for additonal information Identifier: NCT00122473    
Other Study ID Numbers: ADO/VOD DFSP 001
First Posted: July 22, 2005    Key Record Dates
Last Update Posted: July 29, 2011
Last Verified: July 2011
Keywords provided by Dermatologic Cooperative Oncology Group:
Tyrosine Kinase Inhibitor
Additional relevant MeSH terms:
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Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action