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NCT Number: NCT06536179

New Preclinical and Clinical Approaches to Mesothelioma

This study protocol involves the coordination between UO1 (IRCCS San Raffaele Hospital) and UO2 (Istituto Nazionale Tumori di Napoli - IRCCS G. Pascale) to explore the role of HMGB1 and CXCR4 in cancer treatment and metastasis. UO1 focuses on the role of HMGB1 in inflammation, mesothelioma progression, and tissue repair, as well as developing, in future, possible HMGB1 inhibitors for cancer therapy. UO2 specializes in CXCR4's role in cancer, developing CXCR4 antagonists, and tracking CXCR4-dependent metastasis. The hypothesis is that targeting HMGB1 and CXCR4 pathways will inhibit tumor progression and metastasis, enhancing anti-tumor immunity and improving therapeutic outcomes in cancer.

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Key information

Conditions

Mesothelioma Adenoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Nazionale Tumori IRCCS Fondazione G.Pascale, Naples, Campania, Italy

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About this study

This is a multicentric cross-sectional observational study with an additional blood volume collected during blood sampling performed for normal clinical practice. The enrollment will take

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with Mesothelioma:

Clinical suspicion or histologically confirmed diagnosis of pleural mesothelioma.

  • Candidates for surgical intervention.
  • Age 18 years or older. It is possible to include both male and female patients, male and female patients of reproductive age, as well as breastfeeding women.
  • Capacity to comprehend the study nature and provide autonomously informed consent.

Control Group patients:

  • Absence of pleural mesothelioma but presence of other histologically confirmed diseases (neoplastic, inflammatory, or infectious).
  • Candidates for surgical intervention.
  • Age 18 years or older. It is possible to include both male and female patients, male and female patients of reproductive age, as well breastfeeding women.
  • Ability to understand the study nature and provide autonomously informed consent.

If the patient's diagnosis, whether provisional or definitive, does not confirm the clinical suspicion, they will not undergo further evaluation in the study.

Exclusion criteria

  • Lack of biopsy material.
  • pregnancy.
  • Unwillingness to sign the Informed Consent.

Treatment and study plan

Primary outcomes

  1. To set up spheroids models to study and serve as a platform

    Time frame: 0/baseline

    Number of spheroids with infiltrated macrophages. About of 30% of macrophages infiltrated into spheroids.

  2. To set up spheroids models and serve as a platform

    Time frame: 0/baseline

    Evaluation of macrophages polarization status M1 or M2 based on different genes and proteins expression using qPCR and Flow Cytometry.

  3. To set up organoid models

    Time frame: 0/baseline

    Number of organoids formation. About of 30% of biopsies generated organoids.

  4. Test inhibitors on spheroids and organoids and assess the response of individual patients to therapy

    Time frame: 0/baseline

    Rate of growth to test the efficacy of anti-CSF1R, BoxA and DFL using human mesospheres from MPM primary cell lines derived from patients and monocytes from controls.

Secondary outcomes

  1. To investigate inhibitors of the CXCR4-CXCL12-HMGB1 axis on the crosstalk

    Time frame: 0/baseline

    Percentage of migrated or invaded MPM cell lines NCI-H2052 (BAP1 WT/NF2 MUT) vs NCI-H28 (BAP1 mut/NF2 WT) with and without macrophages in presence of CDDP-Nivolumab (NIVO)-Peptide R54.

  2. To investigate inhibitors of the CXCR4-CXCL12-HMGB1 axis on the crosstalk

    Time frame: 0/baseline

    Percentage of cell death of Tregs/Macrophages from peripheral blood and pleural effusion derived from MPM patients treated with and without R54.

  3. To investigate inhibitors of the CXCR4-CXCL12-HMGB1 axis on the crosstalk

    Time frame: In vivo experiment 3 weeks.

    Overall survival of mice with MPM treated with CDDP-anti-PD-1/R54.

Other outcomes

  1. Repurposing Diflunisal as antitumor drug in MPM

    Time frame: In vivo experiment 3 weeks.

    Overall survival of MPM mice treated with DFL in combination with the gold-standard treatment of MM patients, i.e. checkpoint inhibitors (Nivolumab + Ipilimumab).

Study contacts

Contact information is provided by the study sponsor or research team.

Massimo Crippa, PhD

CONTACT

[email protected]

02-26434833

Sponsors and collaborators

Lead sponsor

Marco Emilio Bianchi

Other

Collaborators

  • Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

Registry information

Official study title

New Preclinical and Clinical Approaches to Mesothelioma, an Archetypal Inflammatory Tumor

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Aug 2, 2024
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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