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

Phase 2

Completed

• Conditions: Osteosarcoma
• Interventions: Drug: Mifamurtide arm; Other: 3 drugs arm

• Registration Number: NCT01459484
• Lead Sponsor: Italian Sarcoma Group

Brief 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

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

Study Timeline

• Study Start: 2011-06-23
• Study First Submitted: 2011-10-19
• Study First Submitted QC: 2011-10-24
• Study First Posted: 2011-10-25
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mifamurtide arm	Mifamurtide arm	Chemotherapy for patients who over express ABCB1/P-glycoprotein (methotrexate, cisplatinum, doxorubicine, ifosfamide + mifamurtide)
3 drugs arm	3 drugs arm	High grade osteosarcoma treatment for patients who do not over express ABCB1/P-glycoprotein

Primary Outcome Measures

Name	Time	Method
Events free survival	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).	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

Secondary Outcome Measures

Name	Time	Method
Overall Survival	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).	Time elapsed for the diagnosis to the death for any cause or to the last follow-up examination.

Trial Locations

Locations (11)

I.R.C.C. - Unit of Medical Oncology; 🇮🇹 Candiolo, Torino, Italy

A.O. Universitaria Meyer; 🇮🇹 Firenze, Italy

FONDAZIONE IRCCS Istituto Nazionale dei Tumori; 🇮🇹 Milano, Italy

Azienda Ospedaliera di Padova; 🇮🇹 Padova, Italy

Istituti Fisioterapici Ospitalieri di Roma; 🇮🇹 Roma, Italy

Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology; 🇮🇹 Torino, Italy

Ospedale Pediatrico Bambin Gesu'; 🇮🇹 Roma, Italy

Presidio Sanitario Gradenigo; 🇮🇹 Torino, TO, Italy

IRCCS Istituto ortopedico Rizzoli; 🇮🇹 Bologna, Italy

Istituto Nazionale Tumori "Fondazione G. Pascale"; 🇮🇹 Napoli, Italy

Istituto Giannina Gaslini; 🇮🇹 Genova, Italy