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OsteosarcomaPhase 2ISG/OS-2NCT01459484

ABCB1/P-glycoprotein Expression as Biologic Stratification Factor for Patients With Non Metastatic Osteosarcoma

A Phase 2 study testing Mifamurtide arm and 3 drugs arm in people with Osteosarcoma, run by Italian Sarcoma Group at 11 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a phase II multicentre, uncontrolled trial including patients ≤ 40 years with non-metastatic extremity high-grade osteosarcoma stratified according to P-glicoprotein expression Read more about this study

Who is it for?
Ages Up to 40 years
Conditions the study is for
Osteosarcoma
What is being tested?
Mifamurtide arm and 3 drugs arm
Could I receive a placebo?
No, everyone receives an active treatment
How many people
225 participants
Where
11 sitesItaly
Study dates
23 Jun 2011to 30 Apr 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 40 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Italy11 sites

  • IRCCS Istituto ortopedico Rizzoli

    Bologna, 40136

  • I.R.C.C. - Unit of Medical Oncology

    Candiolo, Torino, 10060

  • A.O. Universitaria Meyer

    Florence, 50139

  • Istituto Giannina Gaslini

    Genova

  • FONDAZIONE IRCCS Istituto Nazionale dei Tumori

    Milan

  • Istituto Nazionale Tumori "Fondazione G. Pascale"

    Naples, 80131

  • Azienda Ospedaliera di Padova

    Padova

  • Istituti Fisioterapici Ospitalieri di Roma

    Roma

  • Ospedale Pediatrico Bambin Gesu'

    Roma

  • Presidio Sanitario Gradenigo

    Torino, TO, 10153

  • Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology

    Torino, 10126

Other trials in Italy

About this study

Official title: ABCB1/P-glycoprotein Expression as Biologic Stratification Factor for Patients With Non Metastatic Osteosarcoma - Prospective Study (ISG/OS-2)

This is a phase II multicentre, uncontrolled trial including patients ≤ 40 years with non-metastatic extremity high-grade osteosarcoma stratified according to P-glicoprotein expression

Read the detailed description

The main objective of the study is to evaluate the impact on event-free survival (EFS) of a multi-drug chemotherapy approach and mifamurtide treatment in patients with non-metastatic osteosarcoma of the extremities according to the expression of ABCB1/P-glycoprotein

Conditions
Osteosarcoma
Being tested
Mifamurtide arm, 3 drugs arm
Keywords
Non metastatic extremities high grade osteosarcoma
Medical subject headings
Osteosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mifamurtide armDrug

    Also called Methotrexate, Cisplatinum, doxorubicin, ifosfamide

    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 armOther

    Also called methotrexate, cisplatin, doxorubicine

    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

Study groups in NCT01459484
Study groupRoleWhat they receive
Mifamurtide armExperimentalChemotherapy for patients who over express ABCB1/P-glycoprotein (methotrexate, cisplatinum, doxorubicine, ifosfamide + mifamurtide)
Receives: Drug: Mifamurtide arm
3 drugs armOtherHigh grade osteosarcoma treatment for patients who do not over express ABCB1/P-glycoprotein
Receives: Other: 3 drugs arm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Events free survival

    Onset of any event. An event is the defined as disease recurrence (local or distant), death for disease or any other cause, onset of secondary tumors or the last follow-up examination

    Measured: After 5 years from the time to first day of chemotherapy for all patients and from the date of surgery for the Pgp overexpression patients stratified according to tumor necrosis (Good Responders and Poor Responders).

Secondary outcomes (1)

  1. Overall Survival

    Time elapsed for the diagnosis to the death for any cause or to the last follow-up examination.

    Measured: After 5 years from the time to first day of chemotherapy for all patients and from the date of surgery for the Pgp overexpression patients stratified according to tumor necrosis (Good Responders and Poor Responders).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2011 (estimated)
  2. Study start23 Jun 2011
  3. Primary completion30 Apr 2024
  4. Study completion30 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
225 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01459484
Sponsor's protocol ID
ISG/OS-2
Other IDs
2011-001659-36
Acronym
ISG/OS-2
Status last verified
May 2024
First submitted
19 Oct 2011
Last updated
20 May 2024
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 17088985

  • 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.

    PubMed 40825172

  • 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.

    PubMed 35201621

  • 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.

    PubMed 31401903

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mifamurtide arm and 3 drugs arm in people with Osteosarcoma, run by Italian Sarcoma Group at 11 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Events free survival (time frame: After 5 years from the time to first day of chemotherapy for all patients and from the date of surgery for the Pgp overexpression patients stratified according to tumor necrosis (Good Responders and Poor Responders).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01459484, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024.

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