Imatinib in Patients With Desmoid Tumor and Chondrosarcoma

Phase 2

Completed

• Conditions: Advanced Desmoid Tumor; Advanced Chondrosarcoma
• Interventions: Drug: Imatinib Mesylate

• Registration Number: NCT00928525
• Lead Sponsor: Italian Sarcoma Group

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 (PDGF) both in its isoform alpha and beta

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2009-06-25
• Study First Submitted QC: 2009-06-25
• Study First Posted: 2009-06-26
• Status Verified: 2018-12
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Imatinib Mesylate	Imatinib Mesylate	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

Primary Outcome Measures

Name	Time	Method
Tumor response will be evaluated by different imaging techniques	every three months

Trial Locations

Locations (7)

I.R.C.C. - Unit of Medical Oncology; 🇮🇹 Candiolo, Torino, Italy

Centro di Riferimento Oncologico - Unit of Medical Oncology; 🇮🇹 Aviano, Pordenone, Italy

Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I; 🇮🇹 Roma, Italy

Ospedale Gradenigo - Unit of Medical Oncology; 🇮🇹 Torino, Italy

Istituto Nazionale Tumori - Unit of Medical Oncology; 🇮🇹 Milano, Italy

Istituti Ortopedici Rizzoli - Unit of chemotherapy of Muscoloskeletal Tumors; 🇮🇹 Bologna, Italy

Policlinico S.Orsola Malpighi - Unit of Medical Oncology; 🇮🇹 Bologna, Italy