Clinical trial NCT00928525: Imatinib in Patients With Desmoid Tumor and Chondrosarcoma
Official title: Open-label Trial of Imatinib in Patients With Desmoid Tumor and Chondrosarcoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Desmoid Tumor
Advanced Chondrosarcoma
Keywords: PDGFr alpha
PDGFr beta
KIT
Lead sponsor: Italian Sarcoma Group
Sponsor class: NETWORK
First posted: 2009-06-26
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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).

Primary outcomes:
measure: Tumor response will be evaluated by different imaging techniques
timeFrame: every three months
Secondary outcomes:
Other outcomes:
Locations:
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico - Unit of Medical Oncology
state: Pordenone
city: Candiolo
country: Italy
facility: I.R.C.C. - Unit of Medical Oncology
state: Torino
city: Bologna
country: Italy
facility: Istituti Ortopedici Rizzoli - Unit of chemotherapy of Muscoloskeletal Tumors
city: Bologna
country: Italy
facility: Policlinico S.Orsola Malpighi - Unit of Medical Oncology
city: Milano
country: Italy
facility: Istituto Nazionale Tumori - Unit of Medical Oncology
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I
city: Torino
country: Italy
facility: Ospedale Gradenigo - Unit of Medical Oncology
Study officials:
References: