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Imatinib Mesylate in Treating Patients With Recurrent or Refractory Fibromatosis

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.
 
ClinicalTrials.gov Identifier: NCT00287846
Recruitment Status : Completed
First Posted : February 7, 2006
Last Update Posted : August 30, 2016
Sponsor:
Information provided by (Responsible Party):
UNICANCER

Study Description
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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 mesylate and to see how well it works in treating patients with recurrent or refractory aggressive fibromatosis.


Condition or disease Intervention/treatment Phase
Desmoid Tumor Drug: imatinib mesylate Phase 1 Phase 2

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 the non-progression rate in patients after being treated with this drug for 12 months.
  • Determine the toxic effects of this drug in these patients.
  • Determine the tolerance to this drug in these patients.
  • Determine the response rate in patients treated with this drug
  • Determine progression free and overall survival of patients treated with this drug.
  • Determine the quality of life of patients treated with this drug.
  • Correlate clinical, biological, and genomic markers with response and long-term stable disease in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral imatinib mesylate once daily for up to 12 months in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed periodically.

PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicentric Phase I/II Study Evaluating the Efficacy and Toxicity of Imatinib in Adult Patients With Aggressive Fibromatosis That Cannot be Treated by Surgery or Curative Radiotherapy
Study Start Date : September 2004
Actual Primary Completion Date : February 2006
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Imatinib
400 to 800 mg/day for a maximal 12 months study duration.
 Drug: imatinib mesylate


Outcome Measures
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Primary Outcome Measures :
  1. Non-progression rate [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Non-progression rate [ Time Frame: 12 months ]
  2. Toxic effects [ Time Frame: 12 months ]
  3. Tolerance [ Time Frame: 12 months ]
  4. Response rate [ Time Frame: 5 years ]
  5. Progression-free survival [ Time Frame: the time between the inclusion date and the progression date ]
  6. Overall survival [ Time Frame: the time between the inclusion date and the death whathever the cause ]
  7. Quality of life [ Time Frame: 5 years ]
  8. Correlation of clinical, biological, and genomic markers with response and long-term stable disease [ Time Frame: 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00287846


Locations
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Sponsors and Collaborators
UNICANCER
Investigators
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Study Chair: Jean-Yves Blay, MD, PhD Hopital Edouard Herriot - Lyon
More Information
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Publications of Results:
Fayette J, Dufresne A, Penel N, et al.: Imatinib for the treatment of aggressive fibromatosis/desmoid tumors (AF/DT) failing local treatment: updated outcome and predictive factors for progression free survival: a FNCLCC French Sarcoma Group-GETO study. [Abstract] J Clin Oncol 25 (Suppl 18): A-10062, 560s, 2007.

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Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT00287846    
Other Study ID Numbers: CDR0000441039
FRE-FNCLCC-SARCOME-05/0401
EU-20515
First Posted: February 7, 2006    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual Participant data will not be shared at an individual level.
Keywords provided by UNICANCER:
desmoid tumor
Additional relevant MeSH terms:
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Fibromatosis, Aggressive
Fibroma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
 Neoplasms
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action