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Imatinib |
Gleevec; imatinib mesylate |
Clinical Trial: Safety and Efficacy of Imatinib in Dermatofibrosarcoma Protuberans (DFSP)
This study is currently recruiting patients.
Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Dermatofibrosarcoma | Drug: Imatinib (Glivec) | Phase I Phase II |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Soft Tissue Sarcoma
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Open-Label Trial of Glivec® (Imatinib Mesylate) in Patients with Primary Or Recurrent Dermatofibrosarcoma Protuberans
Secondary Outcomes: Rate of relapse within the first 2 years.; Association of tumor response with cytogenetic and receptor expression status.
Expected Total Enrollment: 30
Study start: January 2004; Expected completion: June 2008
Last follow-up: January 2007; Data entry closure: January 2007
Eligibility
Inclusion Criteria:
- histological diagnosis of primary or recurrent dermatofibrosarcoma protuberans
- measurable tumor parameters (by 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
Location and Contact Information
Dirk Schadendorf, MD +49 621 383 2127 d.schadendorf@dkfz.de
Germany, Baden-Württemberg
Skin Cancer Unit, German Cancer Research Center and Department of Dermatology, University Hospital of Mannheim, Mannheim, Baden-Württemberg, 68167, Germany; Recruiting
Selma Ugurel, MD, Principal Investigator
Dirk Schadendorf, MD, Principal Investigator
Annette Novak, Study Nurse, Sub-Investigator
Germany, Niedersachsen
Department of Dermatology, ElbeKliniken - Klinikum Buxtehude, Buxtehude, Niedersachsen, 21614, Germany; Recruiting
Peter Mohr, MD, Principal Investigator
Germany, Saarland
Department of Dermatology, The Saarland University Hospital, HOMBURG / SAAR, Saarland, 66424, Germany; Recruiting
Knuth Rass, MD, Principal Investigator
Claudia Pfoehler, MD, Sub-Investigator
Germany, Sachsen-Anhalt
Department of Dermatology, Martin-Luther-University Halle-Wittenberg, Halle/Saale, Sachsen-Anhalt, 06097, Germany; Recruiting
Peter Helmbold, MD, Principal Investigator
Selma Ugurel, MD, Principal Investigator, Skin Cancer Unit, German Cancer Research Center Heidelberg and Department of Dermatology, University Hospital of Mannheim, Mannheim, Germany
Dirk Schadendorf, MD, Principal Investigator, Skin Cancer Unit, German Cancer Research Center Heidelberg and Department of Dermatology, University Hospital of Mannheim, Mannheim, Germany
More Information
Publications
McArthur GA, Demetri GD, van Oosterom A, Heinrich MC, Debiec-Rychter M, Corless CL, Nikolova Z, Dimitrijevic S, Fletcher JA. Molecular and clinical analysis of locally advanced dermatofibrosarcoma protuberans treated with imatinib: Imatinib Target Exploration Consortium Study B2225. J Clin Oncol. 2005 Feb 1;23(4):866-73.
Labropoulos SV, Fletcher JA, Oliveira AM, Papadopoulos S, Razis ED. Sustained complete remission of metastatic dermatofibrosarcoma protuberans with imatinib mesylate. Anticancer Drugs. 2005 Apr;16(4):461-6.
Price VE, Fletcher JA, Zielenska M, Cole W, Viero S, Manson DE, Stuart M, Pappo AS. Imatinib mesylate: an attractive alternative in young children with large, surgically challenging dermatofibrosarcoma protuberans. Pediatr Blood Cancer. 2005 May;44(5):511-5.
Mizutani K, Tamada Y, Hara K, Tsuzuki T, Saeki H, Tamaki K, Matsumoto Y. Imatinib mesylate inhibits the growth of metastatic lung lesions in a patient with dermatofibrosarcoma protuberans. Br J Dermatol. 2004 Jul;151(1):235-7. Review. No abstract available.
McArthur G. Molecularly targeted treatment for dermatofibrosarcoma protuberans. Semin Oncol. 2004 Apr;31(2 Suppl 6):30-6. Review.
Sirvent N, Maire G, Pedeutour F. Genetics of dermatofibrosarcoma protuberans family of tumors: from ring chromosomes to tyrosine kinase inhibitor treatment. Genes Chromosomes Cancer. 2003 May;37(1):1-19. Review.
Maki RG, Awan RA, Dixon RH, Jhanwar S, Antonescu CR. Differential sensitivity to imatinib of 2 patients with metastatic sarcoma arising from dermatofibrosarcoma protuberans. Int J Cancer. 2002 Aug 20;100(6):623-6.
Rubin BP, Schuetze SM, Eary JF, Norwood TH, Mirza S, Conrad EU, Bruckner JD. Molecular targeting of platelet-derived growth factor B by imatinib mesylate in a patient with metastatic dermatofibrosarcoma protuberans. J Clin Oncol. 2002 Sep 1;20(17):3586-91.
Sjoblom T, Shimizu A, O''''Brien KP, Pietras K, Dal Cin P, Buchdunger E, Dumanski JP, Ostman A, Heldin CH. Growth inhibition of dermatofibrosarcoma protuberans tumors by the platelet-derived growth factor receptor antagonist STI571 through induction of apoptosis. Cancer Res. 2001 Aug 1;61(15):5778-83.
Greco A, Roccato E, Miranda C, Cleris L, Formelli F, Pierotti MA. Growth-inhibitory effect of STI571 on cells transformed by the COL1A1/PDGFB rearrangement. Int J Cancer. 2001 May 1;92(3):354-60.
Shimizu A, O''''Brien KP, Sjoblom T, Pietras K, Buchdunger E, Collins VP, Heldin CH, Dumanski JP, Ostman A. The dermatofibrosarcoma protuberans-associated collagen type Ialpha1/platelet-derived growth factor (PDGF) B-chain fusion gene generates a transforming protein that is processed to functional PDGF-BB. Cancer Res. 1999 Aug 1;59(15):3719-23.
Record last reviewed: July 2005
Last Updated: July 25, 2005
Record first received: July 21, 2005
ClinicalTrials.gov Identifier: NCT00122473
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-07-26
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