Imatinib in Patients With Desmoid Tumor and Chondrosarcoma

Advanced Chondrosarcoma Clinical Trial

— Basket 1  

Official title:

Open-label Trial of Imatinib in Patients With Desmoid Tumor and Chondrosarcoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00928525
• Other study ID #: CSTI571 Basket 1
• Secondary ID: EudraCT Number:
• Status: Completed
• Phase: Phase 2
• Start date: May 2007
• Est. completion date: December 2018

Study information

• Verified date: December 2018
• Source: Italian Sarcoma Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Histological diagnosis of DT or CDS.

• Biomolecular or immunohistochemical evidence of Imatinib mesylate target (KIT, PDGFRa PDGFRß activation and/or presence of PDGFa or PDGFß)

• 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).

Related Conditions & MeSH terms

• Advanced Chondrosarcoma
• Advanced Desmoid Tumor
• Chondrosarcoma

Intervention

Drug:
• Imatinib Mesylate
800 mg p.o./day (400 mg b.i.d.) for a maximum of 24 months

Locations

Country	Name	City	State
Italy	Centro di Riferimento Oncologico - Unit of Medical Oncology	Aviano	Pordenone
Italy	Istituti Ortopedici Rizzoli - Unit of chemotherapy of Muscoloskeletal Tumors	Bologna
Italy	Policlinico S.Orsola Malpighi - Unit of Medical Oncology	Bologna
Italy	I.R.C.C. - Unit of Medical Oncology	Candiolo	Torino
Italy	Istituto Nazionale Tumori - Unit of Medical Oncology	Milano
Italy	Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I	Roma
Italy	Ospedale Gradenigo - Unit of Medical Oncology	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Italian Sarcoma Group

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor response will be evaluated by different imaging techniques		every three months