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
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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