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The objective of the present study is to evaluate the activity and safety of imatinib in patients with aggressive fibromatosis who, after receiving the standard therapy, show an inoperable recurrent tumor or disease not readily controllable by surgery or radiotherapy.
Phase II Study to Evaluate Glivec (Imatinib Mesylate) to Induce Progression Arrest in Aggressive Fibromatosis / Desmoid Tumors Not Amenable to Surgical Resection With R0 Intent or Accompanied by Unacceptable Function Loss
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with histological confirmed aggressive fibromatosis (desmoid tumor)
Measurable disease according to the RECIST criteria
Evidence of relapse or disease progression within the last 6 months (based on RECIST criteria) in computed tomography or magnetic resonance imaging
No possibility of complete surgical resection or cases in which surgical therapy leaving a large tissue defect, functional deficit or disfigurement would be required
No possibility of curative radiotherapy with acceptable toxicity and/or late morbidity
Previous treatment of the tumor region by surgical intervention and/or radiotherapy and/or antihormonal therapy possible
Age > or = 18 years
WHO PS < or = 1
Effective contraception during study medication
Signed informed consent form
Surgical intervention < 4 weeks
Prior therapy with imatinib
Pregnancy or lactation
Severe hepatic dysfunction
Known allergic reaction to imatinib or one of its components
The following laboratory values: Absolute neutrophil count < 1.5 x 103/mm3, Platelets < 100,000/mm3, Serum creatinine > or = 2.5 mg/dl, SGOT and/or SGPT > 2.5 x ULN (upper limit of normal), Total bilirubin > 1.5 x ULN
Participation in another study (four weeks before and during the study)
Prior malignancy apart from completely resected basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix