Imatinib in Dermatofibrosarcoma Protuberans (DFSP)

This study has been completed.
Sponsor:
Information provided by:
Dermatologic Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00122473
First received: July 20, 2005
Last updated: July 28, 2011
Last verified: July 2011
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00122473

Locations
Germany
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
Investigators
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:

ClinicalTrials.gov Identifier: NCT00122473     History of Changes
Other Study ID Numbers: ADO/VOD DFSP 001, CSTI571BDE25
Study First Received: July 20, 2005
Last Updated: July 28, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dermatologic Cooperative Oncology Group:
Dermatofibrosarcoma
Imatinib
Tyrosine Kinase Inhibitor

Additional relevant MeSH terms:
Dermatofibrosarcoma
Fibrosarcoma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014