Imatinib in Patients With Desmoid Tumor and Chondrosarcoma (Basket 1)
This study is currently recruiting participants.
Verified March 2013 by Italian Sarcoma Group
Sponsor:
Italian Sarcoma Group
Information provided by (Responsible Party):
Prof. Massimo Aglietta, Italian Sarcoma Group
ClinicalTrials.gov Identifier:
NCT00928525
First received: June 25, 2009
Last updated: March 26, 2013
Last verified: March 2013
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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:
Genetics Home Reference related topics:
desmoid tumor
MedlinePlus related topics:
Cancer
U.S. FDA Resources
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 2013 |
| Estimated Primary Completion Date: | September 2013 (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
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 | |
| 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 | |
| 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 | |
| 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: | March 26, 2013 |
| 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 Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Sarcoma Fibroma |
Neoplasms, Fibrous Tissue Imatinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013