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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Italian Sarcoma Group
Sponsor:
Information provided by (Responsible Party):
Prof. Massimo Aglietta, Italian Sarcoma Group
ClinicalTrials.gov Identifier:
NCT00928525
First received: June 25, 2009
Last updated: September 3, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention Phase
Advanced Desmoid Tumor
Advanced Chondrosarcoma
Drug: Imatinib Mesylate
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-label Trial of Imatinib in Patients With Desmoid Tumor and Chondrosarcoma

Resource links provided by NLM:


Further study details as provided by Italian Sarcoma Group:

Primary Outcome Measures:
  • Tumor response will be evaluated by different imaging techniques [ Time Frame: every three months ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: May 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00928525

Contacts
Contact: Giovanni Grignani, MD +39.011.9933 ext 278 giovanni.grignani@ircc.it
Contact: Luisa Gioeni, Pharmacist +39.011.9933 ext 278 luisa.gioeni@ircc.it

Locations
Italy
Centro di Riferimento Oncologico - Unit of Medical Oncology Recruiting
Aviano, Pordenone, Italy, 33081
Contact: Sergio Frustaci, MD       sfrustaci@cro.it   
Contact: Angela Buonadonna, MD       abuonadonna@cro.it   
Principal Investigator: Sergio Frustaci, MD         
Sub-Investigator: Angela Buonadonna, MD         
I.R.C.C. - Unit of Medical Oncology Recruiting
Candiolo, Torino, Italy, 10060
Contact: Giovanni Grignani, MD    +39.011.9933 ext 278    giovanni.grignani@ircc.it   
Contact: Luisa Gioeni, Pharmacist    +39.011.9933 ext 278    luisa.gioeni@ircc.it   
Sub-Investigator: Giovanni Grignani, MD         
Principal Investigator: Massimo Aglietta, MD         
Istituti Ortopedici Rizzoli - Unit of chemotherapy of Muscoloskeletal Tumors Recruiting
Bologna, Italy, 40136
Contact: Stefano Ferrari, MD       stefano.ferrari@ior.it   
Contact: Emanuela Palmerini, MD       emanuela.palmerini@ior.it   
Principal Investigator: Stefano Ferrari, MD         
Sub-Investigator: Emanuela Palmerini, MD         
Policlinico S.Orsola Malpighi - Unit of Medical Oncology Recruiting
Bologna, Italy, 40138
Contact: Guido Biasco, MD       guido.biasco@unibo.it   
Contact: Monica Di Battista, MD       monica.dibattista@tin.it   
Principal Investigator: Guido Biasco, MD         
Sub-Investigator: Monica Di Battista, MD         
Istituto Nazionale Tumori - Unit of Medical Oncology Recruiting
Milano, Italy, 20133
Contact: Paolo Casali, MD       Paolo.Casali@istitutotumori.mi.it   
Contact: Silvia Stacchiotti, MD       Silvia.Stacchiotti@istitutotumori.mi.it   
Principal Investigator: Paolo Casali, MD         
Sub-Investigator: Silvia Stacchiotti, MD         
Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I Recruiting
Roma, Italy, 00144
Contact: Francesco Cognetti, MD       cognetti@ifo.it   
Contact: Virginia Ferraresi, MD       ferraresi@ifo.it   
Principal Investigator: Francesco Cognetti, MD         
Sub-Investigator: Virginia Ferraresi, MD         
Ospedale Gradenigo - Unit of Medical Oncology Recruiting
Torino, Italy, 10153
Contact: Alessandro Comandone, MD       alessandro.comandone@h-gradenigo.it   
Contact: Alessandra Boglione, MD       alessandra.boglione@h-gradenigo.it   
Principal Investigator: Alessandro Comandone, MD         
Sub-Investigator: Alessandra Boglione, MD         
Sponsors and Collaborators
Italian Sarcoma Group
  More Information

No publications provided

Responsible Party: Prof. Massimo Aglietta, Professor, Italian Sarcoma Group
ClinicalTrials.gov Identifier: NCT00928525     History of Changes
Other Study ID Numbers: CSTI571 Basket 1, EudraCT Number: 2006-006446-33
Study First Received: June 25, 2009
Last Updated: September 3, 2014
Health Authority: Italy: Ministry of Health
Italy: AIFA (Agenzia Italiana del FArmaco) - Osservatorio per le Sperimentaziooni Cliniche

Keywords provided by Italian Sarcoma Group:
PDGFr alpha
PDGFr beta
KIT

Additional relevant MeSH terms:
Chondrosarcoma
Fibromatosis, Aggressive
Fibroma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms, Fibrous Tissue
Sarcoma
Imatinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014