Imatinib in Patients With Desmoid Tumor and Chondrosarcoma (Basket 1)

Italian Sarcoma Group

Status and phase

Completed

Phase 2

Conditions

Advanced Desmoid Tumor

Advanced Chondrosarcoma

Treatments

Drug: Imatinib Mesylate

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT00928525

EudraCT Number: 2006-006446-33

CSTI571 Basket 1

Details and patient eligibility

About

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

Enrollment

35 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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).