Clinical trial · Interventional
Imatinib in Dermatofibrosarcoma Protuberans (DFSP)
Open-label Trial of Glivec® (Imatinib Mesylate) in Patients With Primary or Recurrent Dermatofibrosarcoma Protuberans
NCT00122473CI-TRIAL-00005294completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether imatinib is effective in the treatment of primary and recurrent dermatofibrosarcoma protuberans (DFSP).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dermatofibrosarcoma | Dermatofibrosarcoma Protuberans | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imatinib (Glivec) | Drug | Imatinib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Tumor response at 6 and 12 weeks
Secondary outcomes (2)
- measure
- Rate of relapse within the first 2 years
- measure
- Association of tumor response with cytogenetic and receptor expression status
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (11)
- BACKGROUNDMcArthur 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. doi: 10.1200/JCO.2005.07.088. PMID 15681532
- BACKGROUNDLabropoulos 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. doi: 10.1097/00001813-200504000-00014. PMID 15746584
- BACKGROUNDPrice 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. doi: 10.1002/pbc.20249. PMID 15503291
- BACKGROUNDMizutani 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. doi: 10.1111/j.1365-2133.2004.06024.x. No abstract available. PMID 15270901
- BACKGROUNDMcArthur G. Molecularly targeted treatment for dermatofibrosarcoma protuberans. Semin Oncol. 2004 Apr;31(2 Suppl 6):30-6. doi: 10.1053/j.seminoncol.2004.03.038. PMID 15176002
- BACKGROUNDSirvent 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. doi: 10.1002/gcc.10202. PMID 12661001
- BACKGROUNDMaki 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. doi: 10.1002/ijc.10535.