Imatinib in Patients With Desmoid Tumor and Chondrosarcoma

NCT00928525 | Completed Phase 2 DMC

• 2 other identifiers: CSTI571 Basket 1EudraCT Number: 2006-006446-33
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 7

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

Keywords

PDGFr alpha; PDGFr beta; KIT

Outcome Measures

Primary Outcomes (1)

• Tumor response will be evaluated by different imaging techniques

  every three months

Study Arms (1)

Imatinib Mesylate

EXPERIMENTAL

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

Drug: Imatinib Mesylate

Interventions

Imatinib Mesylate DRUG

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

Imatinib Mesylate

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Italian Sarcoma Group: lead

Study Sites (7)

Centro di Riferimento Oncologico - Unit of Medical Oncology

Aviano, Pordenone, 33081, Italy

Location

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

Candiolo, Torino, 10060, Italy

Location

Istituti Ortopedici Rizzoli - Unit of chemotherapy of Muscoloskeletal Tumors

Bologna, 40136, Italy

Location

Policlinico S.Orsola Malpighi - Unit of Medical Oncology

Bologna, 40138, Italy

Location

Istituto Nazionale Tumori - Unit of Medical Oncology

Milan, 20133, Italy

Location

Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I

Roma, 00144, Italy

Location

Ospedale Gradenigo - Unit of Medical Oncology

Torino, 10153, Italy

Location

MeSH Terms

Interventions

Imatinib Mesylate

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2009
• First Posted: June 26, 2009
• Study Start: May 1, 2007
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 5, 2023

Record last verified: 2018-12

Locations

IT (7)