ABCB1/P-glycoprotein Expression as Biologic Stratification Factor for Patients With Non Metastatic Osteosarcoma
NCT ID: NCT01459484
Last Updated: 2024-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
225 participants
INTERVENTIONAL
2011-06-23
2024-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Mifamurtide arm
Chemotherapy for patients who over express ABCB1/P-glycoprotein (methotrexate, cisplatinum, doxorubicine, ifosfamide + mifamurtide)
Mifamurtide arm
PRE SUGERY TREATMENT:
Methotrexate: 12g/m2 (3 cycles) Cisplatinum: 120mg/m2 (3 cycles) Doxorubicin: ADM 75mg/m2 (3 cycles)
POST SURGERY TREATMENT for good responder patients with positive P-GLYCOPROTEIN
Methotrexate 12g/m2 (10 Cycles) Cisplatinum 120mg/m2; Doxorubicin 90mg/m2 MEPACT 2 mg/m2 twice a week for the first 3 months the weekly for the next 6 months (total lenght treatment 44 weeks)
POST SURGERY TREATMENT for poor responder patients with positive P-GLYCOPROTEIN
Methotrexate 12g/m2; Cisplatinum 120mg/m2; Doxorubicin 90mg/m2 ifosfamide 15g/m2 MEPACT 2 mg/m2 twice a week for the first 3 months the weekly for the next 6 months (total lenght treatment 44 weeks)
All the product are used as commercial formulation
3 drugs arm
High grade osteosarcoma treatment for patients who do not over express ABCB1/P-glycoprotein
3 drugs arm
High grade osteosarcoma who do not over express ABCB1/P-glycoprotein will be treated with a standard 3-drugs regimen
PRE-SUGERY TREATMENT:
Methotrexate: 12g/m2 (3 cycles) Cisplatinum: 120mg/m2 (3 cycles) Doxorubicin: ADM 75mg/m2 (3 cycles)
POST SURGERY TREATMENT:
Methotrexate 12g/m2 (10 cycles) Cisplatinum 120mg/m2; Doxorubicin 90mg/m2
Total lenght 34 weeks
All the product are used as commercial formulation
Interventions
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Mifamurtide arm
PRE SUGERY TREATMENT:
Methotrexate: 12g/m2 (3 cycles) Cisplatinum: 120mg/m2 (3 cycles) Doxorubicin: ADM 75mg/m2 (3 cycles)
POST SURGERY TREATMENT for good responder patients with positive P-GLYCOPROTEIN
Methotrexate 12g/m2 (10 Cycles) Cisplatinum 120mg/m2; Doxorubicin 90mg/m2 MEPACT 2 mg/m2 twice a week for the first 3 months the weekly for the next 6 months (total lenght treatment 44 weeks)
POST SURGERY TREATMENT for poor responder patients with positive P-GLYCOPROTEIN
Methotrexate 12g/m2; Cisplatinum 120mg/m2; Doxorubicin 90mg/m2 ifosfamide 15g/m2 MEPACT 2 mg/m2 twice a week for the first 3 months the weekly for the next 6 months (total lenght treatment 44 weeks)
All the product are used as commercial formulation
3 drugs arm
High grade osteosarcoma who do not over express ABCB1/P-glycoprotein will be treated with a standard 3-drugs regimen
PRE-SUGERY TREATMENT:
Methotrexate: 12g/m2 (3 cycles) Cisplatinum: 120mg/m2 (3 cycles) Doxorubicin: ADM 75mg/m2 (3 cycles)
POST SURGERY TREATMENT:
Methotrexate 12g/m2 (10 cycles) Cisplatinum 120mg/m2; Doxorubicin 90mg/m2
Total lenght 34 weeks
All the product are used as commercial formulation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≤ 40 years
* Localized disease or presence of skip metastasis
* Hepatic, renal and bone marrow normal function
* LVEF \> 50%
* No previous surgery and/ or chemotheraputic osteosarcoma treatments,
* No more than 4 weeks interval between histological diagnosis and start of chemotherapy
* Informed consent to the study participation obtained.
Exclusion Criteria
* Periosteal Osteosarcoma, parostal osteosarcoma, secondary osteosarcoma,
* Medical contra-indication to the drugs foreseen in the protocol,
* Subject is pregnant or breast feeding
* Mental or social conditions that can compromise a correct adherence to the protocol and its procedures
40 Years
ALL
No
Sponsors
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Italian Sarcoma Group
NETWORK
Responsible Party
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Principal Investigators
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Emanuela Palmerini, MD
Role: PRINCIPAL_INVESTIGATOR
Istituto Ortopedico Rizzoli
Locations
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I.R.C.C. - Unit of Medical Oncology
Candiolo, Torino, Italy
Presidio Sanitario Gradenigo
Torino, TO, Italy
IRCCS Istituto ortopedico Rizzoli
Bologna, , Italy
A.O. Universitaria Meyer
Florence, , Italy
Istituto Giannina Gaslini
Genova, , Italy
FONDAZIONE IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Istituto Nazionale Tumori "Fondazione G. Pascale"
Napoli, , Italy
Azienda Ospedaliera di Padova
Padua, , Italy
Istituti Fisioterapici Ospitalieri di Roma
Roma, , Italy
Ospedale Pediatrico Bambin Gesu'
Roma, , Italy
Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology
Torino, , Italy
Countries
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References
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Serra M, Pasello M, Manara MC, Scotlandi K, Ferrari S, Bertoni F, Mercuri M, Alvegard TA, Picci P, Bacci G, Smeland S. May P-glycoprotein status be used to stratify high-grade osteosarcoma patients? Results from the Italian/Scandinavian Sarcoma Group 1 treatment protocol. Int J Oncol. 2006 Dec;29(6):1459-68.
Palmerini E, Meazza C, Tamburini A, Marquez-Vega C, Bisogno G, Fagioli F, Ferraresi V, Milano GM, Coccoli L, Rubio-San-Simon A, Gallego O, Llinares Riestra ME, Manzitti C, Mora J, Vaz-Salgado MA, Luksch R, Mata C, Pierini M, Carretta E, Cesari M, Paioli A, Marrari A, Scotlandi K, Serra M, Asaftei SD, Gambarotti M, Picci P, Ferrari S, Valverde C, Ibrahim T, Broto JM. Is There a Role for Mifamurtide in Nonmetastatic High-Grade Osteosarcoma? Results From the Italian Sarcoma Group (ISG/OS-2) and Spanish Sarcoma Group (GEIS-33) Trials. J Clin Oncol. 2025 Oct;43(28):3113-3122. doi: 10.1200/JCO-25-00210. Epub 2025 Aug 18.
Palmerini E, Meazza C, Tamburini A, Bisogno G, Ferraresi V, Asaftei SD, Milano GM, Coccoli L, Manzitti C, Luksch R, Serra M, Gambarotti M, Donati DM, Scotlandi K, Bertulli R, Favre C, Longhi A, Abate ME, Perrotta S, Mascarin M, D'Angelo P, Cesari M, Staals EL, Marchesi E, Carretta E, Ibrahim T, Casali PG, Picci P, Fagioli F, Ferrari S. Phase 2 study for nonmetastatic extremity high-grade osteosarcoma in pediatric and adolescent and young adult patients with a risk-adapted strategy based on ABCB1/P-glycoprotein expression: An Italian Sarcoma Group trial (ISG/OS-2). Cancer. 2022 May 15;128(10):1958-1966. doi: 10.1002/cncr.34131. Epub 2022 Feb 24.
Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14.
Other Identifiers
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2011-001659-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ISG/OS-2
Identifier Type: -
Identifier Source: org_study_id
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