Imatinib in Dermatofibrosarcoma Protuberans (DFSP)
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| ClinicalTrials.gov Identifier: NCT00122473 |
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Recruitment Status :
Completed
First Posted : July 22, 2005
Last Update Posted : July 29, 2011
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Sponsor:
Dermatologic Cooperative Oncology Group
Information provided by:
Dermatologic Cooperative Oncology Group
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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 |
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 (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 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Dermatofibrosarcoma protuberans
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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
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 ClinicalTrials.gov identifier (NCT number): 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 |
Publications:
| ClinicalTrials.gov Identifier: | NCT00122473 |
| Other Study ID Numbers: |
ADO/VOD DFSP 001 CSTI571BDE25 |
| 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:
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Dermatofibrosarcoma Imatinib Tyrosine Kinase Inhibitor |
Additional relevant MeSH terms:
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Dermatofibrosarcoma Fibrosarcoma Neoplasms, Fibrous Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms |
Sarcoma Imatinib Mesylate Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |