search
Back to results

Imatinib Mesylate in Treating Patients With Recurrent or Refractory Fibromatosis

Primary Purpose

Desmoid Tumor

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
imatinib mesylate
Sponsored by
UNICANCER
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Desmoid Tumor focused on measuring desmoid tumor

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Paul Papin
  • Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
  • Institut Bergonie
  • Centre Regional Francois Baclesse
  • Centre Oscar Lambret
  • Centre Leon Berard
  • Hopital Edouard Herriot - Lyon
  • CHU de la Timone
  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
  • CRLCC Nantes - Atlantique
  • Institut Curie Hopital
  • Hopital Tenon
  • Institut Jean Godinot
  • Centre Eugene Marquis
  • Centre Henri Becquerel
  • Centre Rene Huguenin
  • Centre Paul Strauss
  • Hopitaux Universitaire de Strasbourg
  • Hopital Foch
  • Institut Claudius Regaud
  • Centre Hospitalier Universitaire Bretonneau de Tours
  • Centre Alexis Vautrin
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Imatinib

Arm Description

400 to 800 mg/day for a maximal 12 months study duration.

Outcomes

Primary Outcome Measures

Non-progression rate

Secondary Outcome Measures

Non-progression rate
Toxic effects
Tolerance
Response rate
Progression-free survival
Overall survival
Quality of life
Correlation of clinical, biological, and genomic markers with response and long-term stable disease

Full Information

First Posted
February 6, 2006
Last Updated
August 29, 2016
Sponsor
UNICANCER
search

1. Study Identification

Unique Protocol Identification Number
NCT00287846
Brief Title
Imatinib Mesylate in Treating Patients With Recurrent or Refractory Fibromatosis
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 Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNICANCER

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Desmoid Tumor
Keywords
desmoid tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Imatinib
Arm Type
Experimental
Arm Description
400 to 800 mg/day for a maximal 12 months study duration.
Intervention Type
Drug
Intervention Name(s)
imatinib mesylate
Primary Outcome Measure Information:
Title
Non-progression rate
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Non-progression rate
Time Frame
12 months
Title
Toxic effects
Time Frame
12 months
Title
Tolerance
Time Frame
12 months
Title
Response rate
Time Frame
5 years
Title
Progression-free survival
Time Frame
the time between the inclusion date and the progression date
Title
Overall survival
Time Frame
the time between the inclusion date and the death whathever the cause
Title
Quality of life
Time Frame
5 years
Title
Correlation of clinical, biological, and genomic markers with response and long-term stable disease
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Yves Blay, MD, PhD
Organizational Affiliation
Hopital Edouard Herriot - Lyon
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Paul Papin
City
Angers
ZIP/Postal Code
49036
Country
France
Facility Name
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Regional Francois Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Hopital Edouard Herriot - Lyon
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
CHU de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
CRLCC Nantes - Atlantique
City
Nantes-Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Institut Curie Hopital
City
Paris
ZIP/Postal Code
75248
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Institut Jean Godinot
City
Reims
ZIP/Postal Code
51056
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Centre Rene Huguenin
City
Saint Cloud
ZIP/Postal Code
92211
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg
ZIP/Postal Code
67065
Country
France
Facility Name
Hopitaux Universitaire de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
92151
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31052
Country
France
Facility Name
Centre Hospitalier Universitaire Bretonneau de Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Centre Alexis Vautrin
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual Participant data will not be shared at an individual level.
Citations:
PubMed Identifier
20622000
Citation
Penel N, Le Cesne A, Bui BN, Perol D, Brain EG, Ray-Coquard I, Guillemet C, Chevreau C, Cupissol D, Chabaud S, Jimenez M, Duffaud F, Piperno-Neumann S, Mignot L, Blay JY. Imatinib for progressive and recurrent aggressive fibromatosis (desmoid tumors): an FNCLCC/French Sarcoma Group phase II trial with a long-term follow-up. Ann Oncol. 2011 Feb;22(2):452-7. doi: 10.1093/annonc/mdq341. Epub 2010 Jul 9.
Results Reference
result
Citation
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.
Results Reference
result

Learn more about this trial

Imatinib Mesylate in Treating Patients With Recurrent or Refractory Fibromatosis

We'll reach out to this number within 24 hrs