Imatinib Mesylate in Treating Patients With Recurrent or Refractory Fibromatosis

August 29, 2016 updated by: UNICANCER

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49036
        • Centre Paul Papin
      • Besancon, France, 25030
        • Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
      • Bordeaux, France, 33076
        • Institut Bergonié
      • Caen, France, 14076
        • Centre Regional Francois Baclesse
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Lyon, France, 69437
        • Hopital Edouard Herriot - Lyon
      • Lyon, France, 69373
        • Centre Leon Berard
      • Marseille, France, 13385
        • CHU de la Timone
      • Montpellier, France, 34298
        • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
      • Nantes-Saint Herblain, France, 44805
        • CRLCC Nantes - Atlantique
      • Paris, France, 75970
        • Hopital Tenon
      • Paris, France, 75248
        • Institut Curie Hopital
      • Reims, France, 51056
        • Institut Jean Godinot
      • Rennes, France, 35042
        • Centre Eugene Marquis
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Saint Cloud, France, 92211
        • Centre René Huguenin
      • Strasbourg, France, 67065
        • Centre Paul Strauss
      • Strasbourg, France, 67091
        • Hopitaux Universitaire de Strasbourg
      • Suresnes, France, 92151
        • Hopital Foch
      • Toulouse, France, 31052
        • Institut Claudius Regaud
      • Tours, France, 37044
        • Centre Hospitalier Universitaire Bretonneau de Tours
      • Vandoeuvre-les-Nancy, France, 54511
        • Centre Alexis Vautrin
      • Villejuif, France, F-94805
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Imatinib
400 to 800 mg/day for a maximal 12 months study duration.
Drug: imatinib mesylate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Non-progression rate
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: 5 years
5 years
Response rate
Time Frame: 5 years
5 years
Non-progression rate
Time Frame: 12 months
12 months
Toxic effects
Time Frame: 12 months
12 months
Tolerance
Time Frame: 12 months
12 months
Progression-free survival
Time Frame: the time between the inclusion date and the progression date
the time between the inclusion date and the progression date
Overall survival
Time Frame: the time between the inclusion date and the death whathever the cause
the time between the inclusion date and the death whathever the cause
Correlation of clinical, biological, and genomic markers with response and long-term stable disease
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNICANCER

Investigators

  • Study Chair: Jean-Yves Blay, MD, PhD, Hopital Edouard Herriot - Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (ACTUAL)

February 1, 2006

Study Completion (ACTUAL)

June 1, 2010

Study Registration Dates

First Submitted

February 6, 2006

First Submitted That Met QC Criteria

February 6, 2006

First Posted (ESTIMATE)

February 7, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

August 30, 2016

Last Update Submitted That Met QC Criteria

August 29, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000441039
  • FRE-FNCLCC-SARCOME-05/0401
  • EU-20515

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual Participant data will not be shared at an individual level.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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