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DermatofibrosarcomaPhase 1/2NCT00122473

Imatinib in Dermatofibrosarcoma Protuberans (DFSP)

A Phase 1/2 study testing Imatinib (Glivec) in people with Dermatofibrosarcoma, run by Dermatologic Cooperative Oncology Group at 4 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Dermatofibrosarcoma
What is being tested?
Imatinib (Glivec)
How many people
30 participants
Where
4 sitesGermany
Study dates
Jan 2004to Jan 2007
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

Germany4 sites

  • Department of Dermatology, ElbeKliniken - Klinikum Buxtehude

    Buxtehude, Lower Saxony, 21614

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

    Halle, Saxony-Anhalt, 06097

  • Department of Dermatology, The Saarland University Hospital

    Homburg/Saar, Saarland, 66424

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

    Mannheim, Baden-Wurttemberg, 68167

Other trials in Germany

About this study

Official title: Open-label Trial of Glivec® (Imatinib Mesylate) in Patients With Primary or Recurrent Dermatofibrosarcoma Protuberans

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

Read the 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 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.

Being tested
Imatinib (Glivec)
Keywords
Dermatofibrosarcoma, Imatinib, Tyrosine Kinase Inhibitor
Medical subject headings
Dermatofibrosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Imatinib (Glivec)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tumor response at 6 and 12 weeks

Secondary outcomes (2)

  1. Rate of relapse within the first 2 years

  2. Association of tumor response with cytogenetic and receptor expression status

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2005 (estimated)
  2. Study startJan 2004
  3. Study completionJan 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00122473
Sponsor's protocol ID
ADO/VOD DFSP 001
Other IDs
CSTI571BDE25
Status last verified
Jul 2011
First submitted
20 Jul 2005
Last updated
29 Jul 2011
Results posted
No

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. doi: 10.1200/JCO.2005.07.088.

    PubMed 15681532

  • 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.

    PubMed 15746584

  • 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.

    PubMed 15503291

  • 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.

    PubMed 15270901

  • 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.

    PubMed 15176002

  • 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.

    PubMed 12661001

  • 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.

    PubMed 12209598

  • 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.

    PubMed 12202658

  • 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.

    PubMed 11479215

  • 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.

    PubMed 11291071

  • 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.

    PubMed 10446987

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Imatinib (Glivec) in people with Dermatofibrosarcoma, run by Dermatologic Cooperative Oncology Group at 4 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumor response at 6 and 12 weeks. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00122473, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2011.

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