MedDataX Logo

Imatinib in Dermatofibrosarcoma Protuberans (DFSP)

NCT ID: NCT00122473

Last Updated: 2011-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2007-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dermatofibrosarcoma

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Dermatofibrosarcoma Imatinib Tyrosine Kinase Inhibitor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Imatinib (Glivec)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dermatologic Cooperative Oncology Group

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Selma Ugurel, MD

Role: PRINCIPAL_INVESTIGATOR

Skin Cancer Unit, German Cancer Research Center Heidelberg and Department of Dermatology, University Hospital of Mannheim, Mannheim, Germany

Dirk Schadendorf, MD

Role: PRINCIPAL_INVESTIGATOR

Skin Cancer Unit, German Cancer Research Center Heidelberg and Department of Dermatology, University Hospital of Mannheim, Mannheim, Germany

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Skin Cancer Unit, German Cancer Research Center and Department of Dermatology, University Hospital of Mannheim

Mannheim, Baden-Wurttemberg, Germany

Site Status

Department of Dermatology, ElbeKliniken - Klinikum Buxtehude

Buxtehude, Lower Saxony, Germany

Site Status

Department of Dermatology, The Saarland University Hospital

Homburg/Saar, Saarland, Germany

Site Status

Department of Dermatology, Martin-Luther-University Halle-Wittenberg

Halle, Saxony-Anhalt, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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. doi: 10.1200/JCO.2005.07.088.

Reference Type BACKGROUND
PMID: 15681532 (View on PubMed)

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. doi: 10.1097/00001813-200504000-00014.

Reference Type BACKGROUND
PMID: 15746584 (View on PubMed)

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. doi: 10.1002/pbc.20249.

Reference Type BACKGROUND
PMID: 15503291 (View on PubMed)

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. doi: 10.1111/j.1365-2133.2004.06024.x. No abstract available.

Reference Type BACKGROUND
PMID: 15270901 (View on PubMed)

McArthur 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.

Reference Type BACKGROUND
PMID: 15176002 (View on PubMed)

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. doi: 10.1002/gcc.10202.

Reference Type BACKGROUND
PMID: 12661001 (View on PubMed)

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. doi: 10.1002/ijc.10535.

Reference Type BACKGROUND
PMID: 12209598 (View on PubMed)

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. doi: 10.1200/JCO.2002.01.027.

Reference Type BACKGROUND
PMID: 12202658 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11479215 (View on PubMed)

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. doi: 10.1002/ijc.1190.

Reference Type BACKGROUND
PMID: 11291071 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10446987 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CSTI571BDE25

Identifier Type: -

Identifier Source: secondary_id

ADO/VOD DFSP 001

Identifier Type: -

Identifier Source: org_study_id