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

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

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

Study Overview

• Status: Completed
• Conditions: Advanced Desmoid Tumor; Advanced Chondrosarcoma
• Intervention / Treatment: Drug: Imatinib Mesylate

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Istituti Ortopedici Rizzoli - Unit of chemotherapy of Muscoloskeletal Tumors
  • Bologna, Italy, 40138
    • Policlinico S.Orsola Malpighi - Unit of Medical Oncology
  • Milano, Italy, 20133
    • Istituto Nazionale Tumori - Unit of Medical Oncology
  • Roma, Italy, 00144
    • Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I
  • Torino, Italy, 10153
    • Ospedale Gradenigo - Unit of Medical Oncology
  • Pordenone
    • Aviano, Pordenone, Italy, 33081
      • Centro di Riferimento Oncologico - Unit of Medical Oncology
  • Torino
    • Candiolo, Torino, Italy, 10060
      • I.R.C.C. - Unit of Medical Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Imatinib Mesylate; 800 mg p.o./day (400 mg b.i.d.) for a maximum of 24 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Tumor response will be evaluated by different imaging techniques	every three months

Collaborators and Investigators

• Sponsor: Italian Sarcoma Group

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2007
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: June 25, 2009
• First Submitted That Met QC Criteria: June 25, 2009
• First Posted (Estimated): June 26, 2009

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: KIT; PDGFr alpha; PDGFr beta
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Connective Tissue; Sarcoma; Neoplasms, Fibrous Tissue; Fibroma; Chondrosarcoma; Fibromatosis, Aggressive; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Imatinib Mesylate
• Other Study ID Numbers: CSTI571 Basket 1; EudraCT Number: 2006-006446-33