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Status:

COMPLETED

Imatinib Mesylate in Treating Patients With Recurrent or Refractory Fibromatosis

Lead Sponsor:

UNICANCER

Conditions:

Desmoid Tumor

Eligibility:

All Genders

18-120 years

Phase:

PHASE1

PHASE2

Brief Summary

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I/II trial is studying the side effects of imatinib mesylat...

Detailed Description

OBJECTIVES: Primary * Determine the non-progression rate in patients with recurrent or refractory aggressive fibromatosis after 3 months of treatment with imatinib mesylate. Secondary * Determine ...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed aggressive fibromatosis (desmoid tumor)
  • Relapse or disease progression despite surgery, chemotherapy, radiotherapy, or any other treatment
  • Tumors must meet the following criteria:
  • Ineligible for complete surgical resection by carcinological exeresis OR surgery would cause severe mutilation
  • Cannot be treated with curative radiotherapy
  • Measurable disease by RECIST criteria
  • No prior malignancy
  • PATIENT CHARACTERISTICS:
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 6 months after completion of study treatment
  • Absolute neutrophil count \> 1,000/mm\^3
  • Platelet count \> 100,000/mm\^3
  • Bilirubin \< 1.5 times upper limit of normal (ULN)
  • SGOT and SGPT \< 2.5 times ULN
  • Creatinine ≤ 2.5 times normal
  • No severe liver failure
  • No chronic somatic or psychiatric illness that would preclude study compliance
  • No known hypersensitivity to imatinib mesylate or one of its components
  • No geographical, social, or psychological reason that would inhibit follow-up
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • No concurrent immunomodulators\*
  • No concurrent hormonal treatments\* if used for fibromatosis
  • No concurrent cytotoxic drugs\*
  • No concurrent nonsteroidal anti-inflammatory drug\* if used for fibromatosis
  • Allowed if used as an analgesic 3 months prior to disease progression
  • No concurrent participation in another therapeutic investigational trial NOTE: \*If disease progression has occurred during this treatment, then the treatment must have ended ≥ 1 month prior to study entry

Exclusion

    Key Trial Info

    Start Date :

    September 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 1 2010

    Estimated Enrollment :

    40 Patients enrolled

    Trial Details

    Trial ID

    NCT00287846

    Start Date

    September 1 2004

    End Date

    June 1 2010

    Last Update

    August 30 2016

    Active Locations (23)

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

    Page 1 of 6 (23 locations)

    1

    Centre Paul Papin

    Angers, France, 49036

    2

    Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

    Besançon, France, 25030

    3

    Institut Bergonie

    Bordeaux, France, 33076

    4

    Centre Regional Francois Baclesse

    Caen, France, 14076