Study to Evaluate Imatinib in Desmoid Tumors

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Aggressive Fibromatosis, Desmoid Tumor

Intervention / Treatment
-----------------
* Drug: Imatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: drug<br>Imatinib 800 mg | Drug: Imatinib<br>* 800 mg<br>* Other names: Glivec;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-progression rate after 6 months of treatment |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-progression rate after 12 and 24 months of treatment |  | 12 and 24 months | 
| Response rate |  | 12 and 24 months | 
| Progression-free survival (PFS) and overall survival (OS) |  | 12 and 24 months | 
| Recording of patient quality of life |  | 12 and 24 months |