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Trial record 1 of 1 for:    NCT01459484
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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 : Completed
First Posted : October 25, 2011
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Italian Sarcoma Group

Brief Summary:
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 or disease Intervention/treatment Phase
Osteosarcoma Drug: Mifamurtide arm Other: 3 drugs arm Phase 2 Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 373 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)
Actual Study Start Date : June 23, 2011
Actual Primary Completion Date : March 31, 2018
Actual Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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:
  • Methotrexate
  • Cisplatinum
  • doxorubicin
  • ifosfamide
  • mifamurtide

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:
  • methotrexate
  • cisplatin
  • doxorubicine




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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
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

Information from the National Library of Medicine

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


Locations
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Italy
I.R.C.C. - Unit of Medical Oncology
Candiolo, Torino, Italy, 10060
Presidio Sanitario Gradenigo
Torino, TO, Italy, 10153
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
A.O. Universitaria Meyer
Firenze, Italy, 50139
Istituto Giannina Gaslini
Genova, Italy
FONDAZIONE IRCCS Istituto Nazionale dei Tumori
Milano, Italy
Istituto Nazionale Tumori "Fondazione G. Pascale"
Napoli, Italy, 80131
Azienda Ospedaliera di Padova
Padova, Italy
Istituti Fisioterapici Ospitalieri di Roma
Roma, Italy
Ospedale Pediatrico Bambin Gesu'
Roma, Italy
Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology
Torino, Italy, 10126
Sponsors and Collaborators
Italian Sarcoma Group
Investigators
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Principal Investigator: Stefano Ferrari, MD Italian Sarcoma Group

Publications:
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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: May 10, 2019
Last Verified: May 2019

Keywords provided by Italian Sarcoma Group:
Non metastatic extremities high grade osteosarcoma

Additional relevant MeSH terms:
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Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Doxorubicin
Liposomal doxorubicin
polysaccharide-K
Methotrexate
Ifosfamide
Isophosphamide mustard
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