Clinical trial NCT03737435: Tumor Microenvironment in Patients With Localized Osteosarcoma Treated With Mifamurtide: a Translational Study
Official title: Tumor Microenvironment in Patients With Localized Osteosarcoma Treated With Mifamurtide: a Translational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Localized Osteosarcoma
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2018-11-09
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: male and female without limit of age

Brief summary: International, multicenter retrospecitve biological study

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

Eligibility criteria: Inclusion Criteria:

1. Patients with primary localized osteosarcoma who received chemotherapy +/- 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

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Primary outcomes:
measure: Characterize the immunephenotype in patients with localized osteosarcoma treated with chemotherapy +/- mifamurtide for primary osteosarcoma
timeFrame: at baseline (Day0)
measure: Correlate the rate of immune cells, and the level of the PDL-1 checkpoint with event-free survival and overall-survival
timeFrame: at baseline (Day0)
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: SSD Chemioterapia dei tumori dell'apparato locomotore
Study officials:
References:
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 protocol ISG-OS1. Oncotarget. 2017 Dec 4;8(67):111836-111846. doi: 10.18632/oncotarget.22912. eCollection 2017 Dec 19.
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/srep30093.
citation: 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.
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 Oct 1;56(7):1515-21. doi: 10.1002/1097-0142(19851001)56:73.0.co;2-6.
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. 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.