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Imatinib in Dermatofibrosarcoma Protuberans (DFSP)

This study has been completed.
Information provided by:
Dermatologic Cooperative Oncology Group Identifier:
First received: July 20, 2005
Last updated: July 28, 2011
Last verified: July 2011
The purpose of this study is to determine whether imatinib is effective in the treatment of primary and recurrent dermatofibrosarcoma protuberans (DFSP).

Condition Intervention Phase
Dermatofibrosarcoma Drug: Imatinib (Glivec) Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Dermatologic Cooperative Oncology Group:

Primary Outcome Measures:
  • Tumor response at 6 and 12 weeks

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

Estimated Enrollment: 30
Study Start Date: January 2004
Estimated Study Completion Date: January 2007
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00122473

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
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
  More Information

Publications: Identifier: NCT00122473     History of Changes
Other Study ID Numbers: ADO/VOD DFSP 001
Study First Received: July 20, 2005
Last Updated: July 28, 2011

Keywords provided by Dermatologic Cooperative Oncology Group:
Tyrosine Kinase Inhibitor

Additional relevant MeSH terms:
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 processed this record on August 23, 2017