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Status:

COMPLETED

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

Lead Sponsor:

European Organisation for Research and Treatment of Cancer - EORTC

Conditions:

Sarcoma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 treati...

Detailed Description

OBJECTIVES: Primary * Determine the therapeutic activity of imatinib mesylate in patients with locally advanced or metastatic dermatofibrosarcoma protuberans or giant cell fibroblastoma. * Determine...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • 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
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • WHO 0-2
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Absolute neutrophil count ≥ 2,000/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hemoglobin ≥ 9 mg/dL\* NOTE: \*Transfusion allowed
  • Hepatic
  • 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
  • Renal
  • Creatinine ≤ 1.5 times ULN
  • No uncontrolled renal disease
  • Other
  • 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
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • More than 28 days since prior biologic therapy
  • No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
  • No concurrent anticancer biologic agents
  • Chemotherapy
  • See Disease Characteristics
  • More than 28 days since prior chemotherapy
  • No concurrent chemotherapy
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • 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
  • Surgery
  • Not specified
  • Other
  • 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

Exclusion

    Key Trial Info

    Start Date :

    April 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    17 Patients enrolled

    Trial Details

    Trial ID

    NCT00085475

    Start Date

    April 1 2004

    Last Update

    September 24 2012

    Active Locations (7)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (7 locations)

    1

    Institut Jules Bordet

    Brussels, Belgium, 1000

    2

    U.Z. Gasthuisberg

    Leuven, Belgium, B-3000

    3

    Institut Bergonie

    Bordeaux, France, 33076

    4

    CHU de la Timone

    Marseille, France, 13385