Imatinib in Patients With Desmoid Tumor and Chondrosarcoma

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Imatinib Mesylate is active in diseases - such as Desmoid Tumor and Chondrosarcoma - expressing the receptor for the platelet-derived growth factor (PDGF) both in its isoform alpha and beta

Official Title
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Open-label Trial of Imatinib in Patients With Desmoid Tumor and Chondrosarcoma

Conditions
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Advanced Desmoid Tumor, Advanced Chondrosarcoma

Intervention / Treatment
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* Drug: Imatinib Mesylate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological diagnosis of DT or CDS. Biomolecular or immunohistochemical evidence of Imatinib mesylate target (KIT, PDGFRα PDGFRβ activation and/or presence of PDGFα or PDGFβ) Measurable or evaluable disease Surgical resection of local disease unfeasible radically (or unaccepted by the patient, or amenable to become less demolitive, or easier, or likely more feasible, after cytoreduction) and/or metastatic disease. ECOG Performance status 0, 1, 2 or 3 Adequate bone marrow, liver and renal function Female patients of child-bearing potential must have negative pregnancy test. Male and female patients of reproductive potential must agree to employ an effective method of birth control throughout the study. Written, voluntary, informed consent. Exclusion Criteria: Previous treatment with any other investigational or not investigational agents within 28 days of first day of study drug dosing Other primary malignancy with <5 years clinically assessed disease-free interval, except basal cell skin cancer or cervical carcinoma in situ. Grade III/IV cardiac problems as defined by the New York Heart Association Criteria Severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection) Known brain metastasis. Known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis). Known diagnosis of human immunodeficiency virus (HIV) infection. Previous radiotherapy to >/=25% of the bone marrow or within the previous 2 months on target lesion. Major surgery within 2 weeks prior to study entry. Expected non-compliance to medical regimens (e.g. psychiatric diseases).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Imatinib Mesylate<br>Patients affected by Desmoid Tumor and Chondrosarcoma will receive Imatinib Mesylate 800 mg p.o./day (400 mg b.i.d.) for a maximum of 24 months | Drug: Imatinib Mesylate<br>* 800 mg p.o./day (400 mg b.i.d.) for a maximum of 24 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response will be evaluated by different imaging techniques |  | every three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PDGFr alpha, PDGFr beta, KIT