Imatinib in Patients With Desmoid Tumor and Chondrosarcoma

NCT ID: NCT00928525

Last Updated: 2023-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2018-12-31

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

Conditions

Advanced Desmoid Tumor; Advanced Chondrosarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Imatinib Mesylate

Intervention Type: DRUG

800 mg p.o./day (400 mg b.i.d.) for a maximum of 24 months

Interventions

Imatinib Mesylate

800 mg p.o./day (400 mg b.i.d.) for a maximum of 24 months

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Italian Sarcoma Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centro di Riferimento Oncologico - Unit of Medical Oncology

Aviano, Pordenone, Italy

I.R.C.C. - Unit of Medical Oncology

Candiolo, Torino, Italy

Istituti Ortopedici Rizzoli - Unit of chemotherapy of Muscoloskeletal Tumors

Bologna, , Italy

Policlinico S.Orsola Malpighi - Unit of Medical Oncology

Bologna, , Italy

Istituto Nazionale Tumori - Unit of Medical Oncology

Milan, , Italy

Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I

Roma, , Italy

Ospedale Gradenigo - Unit of Medical Oncology

Torino, , Italy

Countries

Italy

Other Identifiers

EudraCT Number: 2006-006446-33

Identifier Type: -

Identifier Source: secondary_id

CSTI571 Basket 1

Identifier Type: -

Identifier Source: org_study_id