ABCB1/P-glycoprotein Expression as Biologic Stratification Factor for Patients With Non Metastatic Osteosarcoma (ISG/OS-2)
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ClinicalTrials.gov Identifier: NCT01459484 |
Recruitment Status
:
Recruiting
First Posted
: October 25, 2011
Last Update Posted
: April 11, 2018
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Condition or disease | Intervention/treatment | Phase |
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Osteosarcoma | Drug: Mifamurtide arm Other: 3 drugs arm | Phase 2 Phase 3 |
The Primary objective is:
* Overall survival in patient with non metastatic osteosarcoma of the extremities treated with different chemotherapy approach (5 drugs vs 3 drugs), according to the expression of ABCB1/P-glycoprotein
The Secondary objectives are:
- to assess the survival in patient who over express ABCB1/P-glycoprotein, with chemotherapy protocol based on all the 5 available active drugs (Methotrexate, cisplatinum, doxorubicine, ifosfamide and mifamurtide)
- to assess the survival in patient who do not over express ABCB1/P-glycoprotein
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 225 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | ABCB1/P-glycoprotein Expression as Biologic Stratification Factor for Patients With Non Metastatic Osteosarcoma - Prospective Study (ISG/OS-2) |
Study Start Date : | July 2011 |
Estimated Primary Completion Date : | January 2020 |
Estimated Study Completion Date : | February 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: Mifamurtide arm
Chemotherapy for patients who over express ABCB1/P-glycoprotein (methotrexate, cisplatinum, doxorubicine, ifosfamide + mifamurtide)
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Drug: 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 Other Names:
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3 drugs arm
High grade osteosarcoma treatment for patients who do not over express ABCB1/P-glycoprotein
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Other: 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 Names:
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- Overall Survival [ Time Frame: The patients will be followed in term of Overall Survival, for all the study period (expected average: 7 years) ]The Overall Survival will be evaluated at the end of the study period (5 enrollment years and 2 years - minimum- follow-up from the last enrolled patient)
- Events free survival in patient with ABCB1/P-glycoprotein over-expression, and who do not over-express ABCB1/P-glycoprotein [ Time Frame: after 2 and 3 years from the start of study ]The events free survival will be evaluated by means of interim analysis after 2 and 3 years from the start of study. A further evaluation will be performed at the end of enrollment and after 2 years form the last enrolled patient.

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Ages Eligible for Study: | up to 40 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histology confirmed diagnosis of extremities high grade osteosarcoma
- 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:
- Presence of metastases other than skip metastases
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01459484
Contact: Stefano Ferrari, MD | +390516366 ext 411 | stefano.ferrari@ior.it | |
Contact: Emanuela Marchesi, PhD | +390516366 ext 400 | emanuela.marchesi@ior.it |
Italy | |
I.R.C.C. - Unit of Medical Oncology | Not yet 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 | |
Presidio Sanitario Gradenigo | Not yet recruiting |
Torino, TO, Italy, 10153 | |
Contact: Alessandro Comandone, MD +390118151 ext 211 alessandro.comandone@gradenigo.it | |
Principal Investigator: Alessandro Comandone, MD | |
Istituto Ortopedico Rizzoli | Recruiting |
Bologna, Italy, 40136 | |
Contact: Stefano Ferrari, MD +390516366 ext 411 stefano.ferrari@ior.it | |
Contact: Emanuela Marchesi, PhD +390516366 ext 400 emanuela.marchesi@ior.it | |
Principal Investigator: Stefano Ferrari, MD | |
A.O. Universitaria Meyer | Recruiting |
Firenze, Italy, 50139 | |
Contact: Angela Tamburini, MD +3905556 ext 621 a.tamburini@meyer.it | |
Principal Investigator: Angela Tamburini, MD | |
Istituto Giannina Gaslini | Not yet recruiting |
Genova, Italy | |
Contact: Carla Manzitti, MD | |
Principal Investigator: Carla Manzitti, MD | |
FONDAZIONE IRCCS Istituto Nazionale dei Tumori | Recruiting |
Milano, Italy | |
Contact: Rossella Bertulli, MD | |
Principal Investigator: Rossella Bertulli, MD | |
FONDAZIONE IRCCS Istituto Nazionale dei Tumori | Recruiting |
Milano, Italy | |
Contact: Roberto Luksch, MD | |
Principal Investigator: Roberto Luksch, MD | |
Istituto Nazionale Tumori "Fondazione G. Pascale" | Not yet recruiting |
Napoli, Italy, 80131 | |
Contact: Gaetano Apice, MD | |
Principal Investigator: Gaetano Apice, MD | |
Azienda Ospedaliera di Padova | Recruiting |
Padova, Italy | |
Contact: Gianni Bisogno, MD | |
Principal Investigator: Gianni Bisogno, MD | |
Istituti Fisioterapici Ospitalieri di Roma | Recruiting |
Roma, Italy | |
Contact: Virginia Ferraresi, MD | |
Principal Investigator: Virginia Ferraresi, MD | |
Ospedale Pediatrico Bambin Gesu' | Recruiting |
Roma, Italy | |
Contact: Raffaele Cozza, MD | |
Principal Investigator: Raffaele Cozza, MD | |
Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology | Recruiting |
Torino, Italy, 10126 | |
Contact: Franca Fagioli, MD +39.011.3135 ext 230 franca.fagioli@unito.it | |
Principal Investigator: Franca Fagioli, MD |
Principal Investigator: | Stefano Ferrari, MD | Italian Sarcoma Group |
Publications:
Responsible Party: | Italian Sarcoma Group |
ClinicalTrials.gov Identifier: | NCT01459484 History of Changes |
Other Study ID Numbers: |
ISG/OS-2 2011-001659-36 ( EudraCT Number ) |
First Posted: | October 25, 2011 Key Record Dates |
Last Update Posted: | April 11, 2018 |
Last Verified: | April 2018 |
Keywords provided by Italian Sarcoma Group:
Non metastatic extremities high grade osteosarcoma |
Additional relevant MeSH terms:
Osteosarcoma Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Sarcoma Doxorubicin Liposomal doxorubicin Krestin Isophosphamide mustard Methotrexate Ifosfamide Cisplatin Mifamurtide |
Acetylmuramyl-Alanyl-Isoglutamine Antibiotics, Antineoplastic Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Dermatologic Agents Folic Acid Antagonists |