Tumor Microenvironment in Patients With Localized Osteosarcoma Treated With Mifamurtide: a Translational Study

NCT03737435 | Completed

• 1 other identifier: Micros
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

International, multicenter retrospecitve biological study

Conditions

Localized Osteosarcoma

Outcome Measures

Primary Outcomes (2)

• Characterize the immunephenotype in patients with localized osteosarcoma treated with chemotherapy +/- mifamurtide for primary osteosarcoma

  A gene expression profile analysis will be performed through NanoString, using the PanCancer Immune Profiling Panel, which includes 770 genes related to the tumor microenvironment. This analysis will be carried out on the NanoString platform, present at the Hemolympopathology Division of the European Institute of Oncology

  at baseline (Day0)

• Correlate the rate of immune cells, and the level of the PDL-1 checkpoint with event-free survival and overall-survival

  For survival analysis the following factors will be correlated with Overall Suvival and Event Free Survival age (pediatric \< 18 years vs adult ≥ 18 years), gender, LDH and phosphatase alkaline (PA) levels at baseline (normal vs high), pathologic response (good: chemotherapy-induced tumor necrosis ≥ 90%; poor: chemotherapy-induced tumor necrosis \< 90%, \[10\]), tumoral miroenvironment components, PD-1 expression on IC, and PD-L1 both on TC and IC., genetic signatures.

  at baseline (Day0)

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

male and female without limit of age

You may qualify if:

• Patients with primary localized osteosarcoma who received chemotherapy +/- mifamurtide according to ISG-OS2/GEIS-33 trials,
• Paraffin-embedded tissue tumor (FFPE) blocks from archive available to perform the biological analysis
• Written informed consent prior to any study-specific analysis and/or data collection

You may not qualify if:

• \) Patients with diagnosis different from osteosarcoma

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

SSD Chemioterapia dei tumori dell'apparato locomotore

Bologna, 40136, Italy

Location

Related Publications (5)

• Palmerini E, Agostinelli C, Picci P, Pileri S, Marafioti T, Lollini PL, Scotlandi K, Longhi A, Benassi MS, Ferrari S. Tumoral immune-infiltrate (IF), PD-L1 expression and role of CD8/TIA-1 lymphocytes in localized osteosarcoma patients treated within protocol ISG-OS1. Oncotarget. 2017 Dec 4;8(67):111836-111846. doi: 10.18632/oncotarget.22912. eCollection 2017 Dec 19.

  PMID: 29340095 RESULT

• Koirala P, Roth ME, Gill J, Piperdi S, Chinai JM, Geller DS, Hoang BH, Park A, Fremed MA, Zang X, Gorlick R. Immune infiltration and PD-L1 expression in the tumor microenvironment are prognostic in osteosarcoma. Sci Rep. 2016 Jul 26;6:30093. doi: 10.1038/srep30093.

  PMID: 27456063 RESULT

• Dumars C, Ngyuen JM, Gaultier A, Lanel R, Corradini N, Gouin F, Heymann D, Heymann MF. Dysregulation of macrophage polarization is associated with the metastatic process in osteosarcoma. Oncotarget. 2016 Nov 29;7(48):78343-78354. doi: 10.18632/oncotarget.13055.

  PMID: 27823976 RESULT

• Picci P, Bacci G, Campanacci M, Gasparini M, Pilotti S, Cerasoli S, Bertoni F, Guerra A, Capanna R, Albisinni U, et al. Histologic evaluation of necrosis in osteosarcoma induced by chemotherapy. Regional mapping of viable and nonviable tumor. Cancer. 1985 Oct 1;56(7):1515-21. doi: 10.1002/1097-0142(19851001)56:73.0.co;2-6.

  PMID: 3861228 RESULT

• Meyers PA, Schwartz CL, Krailo M, Kleinerman ES, Betcher D, Bernstein ML, Conrad E, Ferguson W, Gebhardt M, Goorin AM, Harris MB, Healey J, Huvos A, Link M, Montebello J, Nadel H, Nieder M, Sato J, Siegal G, Weiner M, Wells R, Wold L, Womer R, Grier H. Osteosarcoma: a randomized, prospective trial of the addition of ifosfamide and/or muramyl tripeptide to cisplatin, doxorubicin, and high-dose methotrexate. J Clin Oncol. 2005 Mar 20;23(9):2004-11. doi: 10.1200/JCO.2005.06.031.

  PMID: 15774791 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

archival samples

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 9, 2018
• Study Start: December 12, 2018
• Primary Completion: October 25, 2024
• Study Completion: October 25, 2024
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)