Status:
COMPLETED
Imatinib in Patients With Desmoid Tumor and Chondrosarcoma
Lead Sponsor:
Italian Sarcoma Group
Conditions:
Advanced Desmoid Tumor
Advanced Chondrosarcoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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 (P...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00928525
Start Date
May 1 2007
End Date
December 1 2018
Last Update
October 5 2023
Active Locations (7)
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1
Centro di Riferimento Oncologico - Unit of Medical Oncology
Aviano, Pordenone, Italy, 33081
2
I.R.C.C. - Unit of Medical Oncology
Candiolo, Torino, Italy, 10060
3
Istituti Ortopedici Rizzoli - Unit of chemotherapy of Muscoloskeletal Tumors
Bologna, Italy, 40136
4
Policlinico S.Orsola Malpighi - Unit of Medical Oncology
Bologna, Italy, 40138