ABCB1/P-glycoprotein Expression as Biologic Stratification Factor for Patients With Non Metastatic Osteosarcoma (ISG/OS-2)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified March 2016 by Italian Sarcoma Group
Sponsor:
Italian Sarcoma Group
Information provided by (Responsible Party):
Italian Sarcoma Group
ClinicalTrials.gov Identifier:
NCT01459484
First received: October 19, 2011
Last updated: March 2, 2016
Last verified: March 2016
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Purpose
The main objective of the study is to assess the survival in patient with non metastatic osteosarcoma of the extremities treated with different chemotherapy protocols, according to the expression of ABCB1/P-glycoprotein
| Condition | Intervention | Phase |
|---|---|---|
|
Osteosarcoma |
Drug: Mifamurtide arm Other: 3 drugs arm |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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) |
Resource links provided by NLM:
Drug Information available for:
Methotrexate
Ifosfamide
Methotrexate sodium
Cisplatin
Doxorubicin
Doxorubicin hydrochloride
Genetic and Rare Diseases Information Center resources:
Bone Cancer
Osteosarcoma
Malignant Mesenchymal Tumor
Soft Tissue Sarcoma
U.S. FDA Resources
Further study details as provided by Italian Sarcoma Group:
Primary Outcome Measures:
- Overall Survival [ Time Frame: The patients will be followed in term of Overall Survival, for all the study period (expected average: 7 years) ] [ Designated as safety issue: No ]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)
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 225 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | February 2020 |
| Estimated Primary Completion Date: | January 2020 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Mifamurtide arm
Chemotherapy for patients who over express ABCB1/P-glycoprotein (methotrexate, cisplatinum, doxorubicine, ifosfamide + mifamurtide)
|
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:
|
|
3 drugs arm
High grade osteosarcoma treatment for patients who do not over express ABCB1/P-glycoprotein
|
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:
|
Detailed Description:
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
Eligibility| Ages Eligible for Study: | up to 40 Years (Child, Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
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: NCT01459484
Please refer to this study by its ClinicalTrials.gov identifier: NCT01459484
Contacts
| Contact: Stefano Ferrari, MD | +390516366 ext 411 | stefano.ferrari@ior.it | |
| Contact: Emanuela Marchesi, PhD | +390516366 ext 400 | emanuela.marchesi@ior.it |
Locations
| 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 | Not yet recruiting |
| Milano, Italy | |
| Contact: Rossella Bertulli, MD | |
| Principal Investigator: Rossella Bertulli, MD | |
| FONDAZIONE IRCCS Istituto Nazionale dei Tumori | Not yet 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 | Not yet recruiting |
| Padova, Italy | |
| Contact: Gianni Bisogno, MD | |
| Principal Investigator: Gianni Bisogno, MD | |
| Istituti Fisioterapici Ospitalieri di Roma | Not yet recruiting |
| Roma, Italy | |
| Contact: Virginia Ferraresi, MD | |
| Principal Investigator: Virginia Ferraresi, MD | |
| Ospedale Pediatrico Bambin Gesu' | Not yet recruiting |
| Roma, Italy | |
| Contact: Raffaele Cozza, MD | |
| Principal Investigator: Raffaele Cozza, MD | |
| Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology | Not yet recruiting |
| Torino, Italy, 10126 | |
| Contact: Franca Fagioli, MD +39.011.3135 ext 230 franca.fagioli@unito.it | |
| Principal Investigator: Franca Fagioli, MD | |
Sponsors and Collaborators
Italian Sarcoma Group
Investigators
| Principal Investigator: | Stefano Ferrari, MD | Italian Sarcoma Group |
More Information
Publications:
| Responsible Party: | Italian Sarcoma Group |
| ClinicalTrials.gov Identifier: | NCT01459484 History of Changes |
| Other Study ID Numbers: | ISG/OS-2 2011-001659-36 |
| Study First Received: | October 19, 2011 |
| Last Updated: | March 2, 2016 |
| Health Authority: | Italy: Ethics Committee |
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 Methotrexate Doxorubicin Liposomal doxorubicin Isophosphamide mustard Krestin Ifosfamide Cisplatin Mifamurtide |
Acetylmuramyl-Alanyl-Isoglutamine Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents |
ClinicalTrials.gov processed this record on September 23, 2016