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

• Status: Active, not recruiting
• Trial end date: 2021-10-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Italian Sarcoma Group
• Treatments: Acetylmuramyl-Alanyl-Isoglutamine; Cisplatin; Doxorubicin; Ifosfamide; Isophosphamide mustard; Krestin; Liposomal doxorubicin; Methotrexate; Mifamurtide

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