Evaluation of the safety and efficacy of Imatinib in Pat. with Desmoid-Tumors
- Conditions
- AGGRESSIVE FIBROMATOSIS / DESMOID TUMORSTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2007-000624-40-DE
- Lead Sponsor
- niversity of Heidelberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 37
• 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 >= 18 years
• WHO PS =< 1
• Effective contraception during study medication and for six months thereafter
• Signed informed consent form
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 37
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 37
• 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 >= 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
• Prior malignancy apart from completely resected basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluation of the activity of imatinib and nilotinib in AF patients with relapsing disease after the standard therapy.;Secondary Objective: Evaluation of the safety of imatinib and nilotinitb in AF patients with relapsing disease after the standard therapy.;Primary end point(s): Non-progression rate after 6 months of treatment;Timepoint(s) of evaluation of this end point: 6 month after start of treatmen
- Secondary Outcome Measures
Name Time Method Secondary end point(s): non-progression rate after 12 and 24 months of treatment<br>response rate (complete remission (CR), partial remission (PR), stable disease (SD) > 12 weeks<br>Progression-free survival (PFS) and overall survival (OS)<br>Tolerability of the treatment<br>Toxic effects<br>recording of patient quality of liefe according to the Toronto Extremity Salvage Score (TESS) at study baseline and end of study visit;Timepoint(s) of evaluation of this end point: 12 months after treatment<br>24 months after treatment