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| ID | Type | Description | Link |
|---|---|---|---|
| FRE-FNCLCC-SARCOME-05/0401 | |||
| EU-20515 |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imatinib | Experimental | 400 to 800 mg/day for a maximal 12 months study duration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| imatinib mesylate | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Non-progression rate | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Non-progression rate | 12 months | |
| Toxic effects | 12 months | |
| Tolerance |
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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:
Measurable disease by RECIST criteria
No prior malignancy
PATIENT CHARACTERISTICS:
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
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
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Yves Blay, MD, PhD | Hopital Edouard Herriot - Lyon | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Paul Papin | Angers | 49036 | France | |||
| Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20622000 | Result | 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. | |
| Result | 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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Individual Participant data will not be shared at an individual level.
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| 12 months |
| Response rate | 5 years |
| Progression-free survival | the time between the inclusion date and the progression date |
| Overall survival | the time between the inclusion date and the death whathever the cause |
| Quality of life | 5 years |
| Correlation of clinical, biological, and genomic markers with response and long-term stable disease | 5 years |
| Besançon |
| 25030 |
| France |
| Institut Bergonie | Bordeaux | 33076 | France |
| Centre Regional Francois Baclesse | Caen | 14076 | France |
| Centre Oscar Lambret | Lille | 59020 | France |
| Centre Leon Berard | Lyon | 69373 | France |
| Hopital Edouard Herriot - Lyon | Lyon | 69437 | France |
| CHU de la Timone | Marseille | 13385 | France |
| Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | Montpellier | 34298 | France |
| CRLCC Nantes - Atlantique | Nantes-Saint Herblain | 44805 | France |
| Institut Curie Hopital | Paris | 75248 | France |
| Hopital Tenon | Paris | 75970 | France |
| Institut Jean Godinot | Reims | 51056 | France |
| Centre Eugene Marquis | Rennes | 35042 | France |
| Centre Henri Becquerel | Rouen | 76038 | France |
| Centre Rene Huguenin | Saint-Cloud | 92211 | France |
| Centre Paul Strauss | Strasbourg | 67065 | France |
| Hopitaux Universitaire de Strasbourg | Strasbourg | 67091 | France |
| Hopital Foch | Suresnes | 92151 | France |
| Institut Claudius Regaud | Toulouse | 31052 | France |
| Centre Hospitalier Universitaire Bretonneau de Tours | Tours | 37044 | France |
| Centre Alexis Vautrin | Vandœuvre-lès-Nancy | 54511 | France |
| Institut Gustave Roussy | Villejuif | F-94805 | France |
| ID | Term |
|---|---|
| D018222 | Desmoid Tumors |
| ID | Term |
|---|---|
| D005350 | Fibroma |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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