Status:
COMPLETED
Imatinib in Dermatofibrosarcoma Protuberans (DFSP)
Lead Sponsor:
Dermatologic Cooperative Oncology Group
Conditions:
Dermatofibrosarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine whether imatinib is effective in the treatment of primary and recurrent dermatofibrosarcoma protuberans (DFSP).
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 fo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00122473
Start Date
January 1 2004
End Date
January 1 2007
Last Update
July 29 2011
Active Locations (4)
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1
Skin Cancer Unit, German Cancer Research Center and Department of Dermatology, University Hospital of Mannheim
Mannheim, Baden-Wurttemberg, Germany, 68167
2
Department of Dermatology, ElbeKliniken - Klinikum Buxtehude
Buxtehude, Lower Saxony, Germany, 21614
3
Department of Dermatology, The Saarland University Hospital
Homburg/Saar, Saarland, Germany, 66424
4
Department of Dermatology, Martin-Luther-University Halle-Wittenberg
Halle, Saxony-Anhalt, Germany, 06097