Imatinib in Dermatofibrosarcoma Protuberans (DFSP)

July 28, 2011 updated by: Dermatologic Cooperative Oncology Group

Open-label Trial of Glivec® (Imatinib Mesylate) in Patients With Primary or Recurrent Dermatofibrosarcoma Protuberans

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Mannheim, Baden-Württemberg, Germany, 68167
        • Skin Cancer Unit, German Cancer Research Center and Department of Dermatology, University Hospital of Mannheim
    • Niedersachsen
      • Buxtehude, Niedersachsen, Germany, 21614
        • Department of Dermatology, ElbeKliniken - Klinikum Buxtehude
    • Saarland
      • Homburg/Saar, Saarland, Germany, 66424
        • Department of Dermatology, The Saarland University Hospital
    • Sachsen-Anhalt
      • Halle/Saale, Sachsen-Anhalt, Germany, 06097
        • Department of Dermatology, Martin-Luther-University Halle-Wittenberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Tumor response at 6 and 12 weeks

Secondary Outcome Measures

Outcome Measure
Rate of relapse within the first 2 years
Association of tumor response with cytogenetic and receptor expression status

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Study Completion

January 1, 2007

Study Registration Dates

First Submitted

July 20, 2005

First Submitted That Met QC Criteria

July 21, 2005

First Posted (Estimate)

July 22, 2005

Study Record Updates

Last Update Posted (Estimate)

July 29, 2011

Last Update Submitted That Met QC Criteria

July 28, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADO/VOD DFSP 001
  • CSTI571BDE25

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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