NCT00122473

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2004

Typical duration for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2005

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

July 29, 2011

Status Verified

July 1, 2011

First QC Date

July 20, 2005

Last Update Submit

July 28, 2011

Conditions

Dermatofibrosarcoma

Keywords

DermatofibrosarcomaImatinibTyrosine Kinase Inhibitor

Outcome Measures

Primary Outcomes (1)

  • Tumor response at 6 and 12 weeks

Secondary Outcomes (2)

  • Rate of relapse within the first 2 years

  • Association of tumor response with cytogenetic and receptor expression status

Interventions

Imatinib (Glivec)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

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

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Department of Dermatology, ElbeKliniken - Klinikum Buxtehude

Buxtehude, Lower Saxony, 21614, Germany

Location

Department of Dermatology, The Saarland University Hospital

Homburg/Saar, Saarland, 66424, Germany

Location

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

Halle, Saxony-Anhalt, 06097, Germany

Location

Related Publications (11)

  • 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.

    PMID: 15681532BACKGROUND

  • 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.

    PMID: 15746584BACKGROUND

  • 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.

    PMID: 15503291BACKGROUND

  • 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.

    PMID: 15270901BACKGROUND

  • 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.

    PMID: 15176002BACKGROUND

  • 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.

    PMID: 12661001BACKGROUND

  • 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.

    PMID: 12209598BACKGROUND

  • 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.

    PMID: 12202658BACKGROUND

  • 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.

    PMID: 11479215BACKGROUND

  • 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.

    PMID: 11291071BACKGROUND

  • 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.

    PMID: 10446987BACKGROUND

MeSH Terms

Conditions

Dermatofibrosarcoma

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

FibrosarcomaNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsSarcoma

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 20, 2005

First Posted

July 22, 2005

Study Start

January 1, 2004

Study Completion

January 1, 2007

Last Updated

July 29, 2011

Record last verified: 2011-07

Locations

DE(4)