Imatinib Mesylate in Treating Patients With Recurrent or Refractory Fibromatosis
Desmoid Tumor
About this trial
This is an interventional treatment trial for Desmoid Tumor focused on measuring desmoid tumor
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
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
Experimental
Imatinib
400 to 800 mg/day for a maximal 12 months study duration.