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Imatinib Mesylate in Treating Patients With Locally Advanced or Metastatic Dermatofibrosarcoma Protuberans or Giant Cell Fibroblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00085475
Recruitment Status : Completed
First Posted : June 11, 2004
Last Update Posted : September 24, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary:

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with locally advanced or metastatic dermatofibrosarcoma protuberans or giant cell fibroblastoma.

Condition or disease Intervention/treatment Phase
Sarcoma Drug: imatinib mesylate Procedure: conventional surgery Phase 2

Detailed Description:



  • Determine the therapeutic activity of imatinib mesylate in patients with locally advanced or metastatic dermatofibrosarcoma protuberans or giant cell fibroblastoma.
  • Determine the progression-free rate at 14 weeks in patients treated with this drug.


  • Determine objective response rate, progression-free survival, and overall survival in patients treated with this drug.
  • Determine the duration of response in patients treated with this drug.

OUTLINE: This is an open-label, non-randomized, multicenter study.

Patients receive oral imatinib mesylate twice daily for at least 14 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable disease after 14 weeks receive imatinib mesylate for 12 additional weeks. Patients with a partial or complete response at 14 weeks undergo surgical resection if possible. If surgical resection of all remaining tumor is not possible OR if complete resection is not achieved (section margins positive), patients continue to receive imatinib mesylate in the absence of disease progression

Patients are followed monthly for 6 months, every 3 months for 6 months, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study within 2 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Glivec (Imatinib) in Locally Advanced and/or Metastatic Soft Tissue Sarcomas Expressing the t(17;22)(q22;q13) Translocation Resulting in a COL1A1/PDGF-beta Fusion Protein i.e. DermatoFibroSarcoma Protuberans (DFSP) and Giant Cell Fibroblastoma (GCF)
Study Start Date : April 2004
Actual Primary Completion Date : April 2007

Primary Outcome Measures :
  1. Progression-free rate at 14 weeks

Secondary Outcome Measures :
  1. Response rate as assessed by RECIST criteria
  2. Progression-free survival
  3. Overall survival
  4. Duration of response
  5. Toxicity as assessed by CTC 3.0

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed dermatofibrosarcoma protuberans or giant cell fibroblastoma

    • Locally advanced or metastatic disease
  • Measurable disease
  • Not amenable to surgery, radiotherapy, or combined modality therapy with curative intent
  • Documented progressive disease within the past 3 months

    • Previously irradiated lesions must show disease progression
  • Tumor expressing COL1A1/PDGF-beta by fluorescence in situ hybridization

    • Translocation t(17;22)(q22;q13)
  • No prior chemotherapy OR previously treated with 1, and only 1, line of combination chemotherapy with ifosfamide and doxorubicin OR 2 lines of single-agent therapy OR relapsed within 6 months after adjuvant chemotherapy



  • 18 and over

Performance status

  • WHO 0-2

Life expectancy

  • Not specified


  • Absolute neutrophil count ≥ 2,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9 mg/dL* NOTE: *Transfusion allowed


  • SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if hepatic metastases are present)
  • Bilirubin ≤ 1.5 times ULN
  • No uncontrolled hepatic disease


  • Creatinine ≤ 1.5 times ULN
  • No uncontrolled renal disease


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • HIV negative
  • No uncontrolled diabetes
  • No active or uncontrolled infection
  • No concurrent severe or uncontrolled medical disease
  • No medical, psychological, familial, sociological, or geographical condition that would preclude study participation, compliance, or giving informed consent
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission


Biologic therapy

  • More than 28 days since prior biologic therapy
  • No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
  • No concurrent anticancer biologic agents


  • See Disease Characteristics
  • More than 28 days since prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy

  • Not specified


  • See Disease Characteristics
  • At least 6 months since prior radiotherapy
  • No concurrent radiotherapy

    • Concurrent palliative radiotherapy allowed provided radiotherapy will not be administered to a target lesion


  • Not specified


  • More than 28 days since prior investigational drugs
  • No concurrent therapeutic anticoagulation therapy with warfarin

    • Concurrent low-molecular weight heparin or mini-dose warfarin for prophylaxis of central venous catheter thrombosis allowed
  • No other concurrent anticancer agents
  • No other concurrent investigational drugs
  • No other concurrent cytostatic agents
  • No other concurrent tyrosine kinase inhibitors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00085475

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Institut Jules Bordet
Brussels, Belgium, 1000
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Institut Bergonie
Bordeaux, France, 33076
CHU de la Timone
Marseille, France, 13385
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands, 1066 CX
Leiden University Medical Center
Leiden, Netherlands, 2300 CA
United Kingdom
Christie Hospital NHS Trust
Manchester, England, United Kingdom, M20 4BX
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
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Study Chair: Allan T. van Oosterom, MD, PhD University Hospital, Gasthuisberg

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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00085475     History of Changes
Other Study ID Numbers: EORTC-62027
First Posted: June 11, 2004    Key Record Dates
Last Update Posted: September 24, 2012
Last Verified: September 2012
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
recurrent adult soft tissue sarcoma
stage III adult soft tissue sarcoma
stage IV adult soft tissue sarcoma
adult fibrosarcoma
adult malignant fibrous histiocytoma
Additional relevant MeSH terms:
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Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action