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

Localized Osteosarcoma Clinical Trial

— Micros  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03737435
• Other study ID #: Micros
• Status: Recruiting
• Start date: December 12, 2018
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: Istituto Ortopedico Rizzoli
• Contact: Emanuela Palmerini, MD
• Phone: +390516966199
• Email: emanuela.palmerini[@]ior.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

International, multicenter retrospecitve biological study

Description:

International, multicenter retrospecitve biological study that will analyze the tumor micro environment in biological archival samples of patients, who were treated with mifamurtide according the protocols for primary localized osteosarcoma (ISG-OS2 and GEIS-33)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Patients with primary localized osteosarcoma who received mifamurtide according to ISG-OS2/GEIS-33 trials,

2. Paraffin-embedded tissue tumor (FFPE) blocks from archive available to perform the biological analysis

3. Written informed consent prior to any study-specific analysis and/or data collection

Exclusion Criteria:

1) Patients with diagnosis different from osteosarcoma 2) Patient not treated with mifamurtide

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Related Conditions & MeSH terms

• Localized Osteosarcoma
• Osteosarcoma

Locations

Country	Name	City	State
Italy	SSD Chemioterapia dei tumori dell'apparato locomotore	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View Citation

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/ — View Citation

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. Os — View Citation

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 prot — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlate the level of the PDL-1 checkpoint with event-free survival and overall-survival	correlation by pSTAT1 and CMAF staining, respectively, for the characterization of M1 and M2 subpopulations. Osteoclastic cells will be evaluated independently as giant multinucleated cells by CD68 staining	at baseline (Day0)