Imatinib in Patients With Desmoid Tumor and Chondrosarcoma
This trial is active, not recruiting.
|Conditions||advanced desmoid tumor, advanced chondrosarcoma|
|Sponsor||Italian Sarcoma Group|
|Start date||May 2007|
|End date||December 2016|
|Trial size||35 participants|
|Trial identifier||NCT00928525, CSTI571 Basket 1, EudraCT Number: 2006-006446-33|
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
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Aviano, Italy||Centro di Riferimento Oncologico - Unit of Medical Oncology||no longer recruiting|
|Candiolo, Italy||I.R.C.C. - Unit of Medical Oncology||no longer recruiting|
|Bologna, Italy||Istituti Ortopedici Rizzoli - Unit of chemotherapy of Muscoloskeletal Tumors||no longer recruiting|
|Bologna, Italy||Policlinico S.Orsola Malpighi - Unit of Medical Oncology||no longer recruiting|
|Milano, Italy||Istituto Nazionale Tumori - Unit of Medical Oncology||no longer recruiting|
|Roma, Italy||Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I||no longer recruiting|
|Torino, Italy||Ospedale Gradenigo - Unit of Medical Oncology||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
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
Tumor response will be evaluated by different imaging techniques
time frame: every three months
Male or female participants from 18 years up to 80 years old.
- 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.
- 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).
|Official title||Open-label Trial of Imatinib in Patients With Desmoid Tumor and Chondrosarcoma|
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