Phase I Clinical Trial on Pleural Mesothelioma Using Neoadjuvant Local Administration of Paclitaxel-Loaded Mesenchymal Stromal Cells (PACLIMES Trial): Study Rationale and Design

<b>Background and rationale.</b> Pleural mesothelioma (PM) is a rare and aggressive neoplasm that originates from the pleural mesothelium and whose onset is mainly linked to exposure to asbestos, which cannot be attacked with truly effective therapies with consequent poor prognosis. The rationale of this study is based on the use of mesenchymal stromal cells (MSCs) as a vehicle for chemotherapy drugs to be injected directly into the pathological site, such as the pleural cavity. <b>Study design.</b> The study involves the use of a conventional chemotherapeutic drug, Paclitaxel (PTX), which is widely used in the treatment of different types of solid tumors, including PM, although some limitations are related to pharmacokinetic aspects. The use of PTX-loaded MSCs to treat PM should provide several potential advantages over the systemically administered drug as reduced toxicity and increased concentration of active drug in the tumor-surrounding context. The PACLIMES trial explores the safety and toxicity of the local administration of Paclimes in chemonaive patients, candidates for pleurectomy. The secondary objective is to find the effective Paclimes dose for subsequent phase II studies and to observe and record the antitumor activity. <b>Future direction</b>. The experimental pre-clinical background and rationale are discussed as well.

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Publication Details

Journal
Cancers
Published
2024-10-04
DOI
https://doi.org/10.3390/cancers16193391
Citations
2
Primary Topic
Occupational and environmental lung diseases
Type
article
Field-Weighted Citation Impact
0.84

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article

Phase I Clinical Trial on Pleural Mesothelioma Using Neoadjuvant Local Administration of Paclitaxel-Loaded Mesenchymal Stromal Cells (PACLIMES Trial): Study Rationale and Design

Giulia Galli, Daniela Lisini, Augusto Pessina, Francesco Agustoni et al.
2 citations
Cancers
Occupational and environmental lung diseases
0.84
article

Phase I Clinical Trial on Pleural Mesothelioma Using Neoadjuvant Local Administration of Paclitaxel-Loaded Mesenchymal Stromal Cells (PACLIMES Trial): Study Rationale and Design

Giulia Galli, Daniela Lisini, Augusto Pessina, Francesco Agustoni, Stefano Tomaselli, Vittorio Rosti, Giulio Melloni, Amelia Grosso, Angelo Guido Corsico, Giulia Maria Stella, Patrizia Comoli, Paolo Pedrazzoli, Francesca Paino, Catherine Klersy, Elena Grignani, Gioacchino D’Ambrosio, Giulio Alessandri, Chandra Bortolotto, Laura Saracino
article en
2 citations

Abstract

<b>Background and rationale.</b> Pleural mesothelioma (PM) is a rare and aggressive neoplasm that originates from the pleural mesothelium and whose onset is mainly linked to exposure to asbestos, which cannot be attacked with truly effective therapies with consequent poor prognosis. The rationale of this study is based on the use of mesenchymal stromal cells (MSCs) as a vehicle for chemotherapy drugs to be injected directly into the pathological site, such as the pleural cavity. <b>Study design.</b> The study involves the use of a conventional chemotherapeutic drug, Paclitaxel (PTX), which is widely used in the treatment of different types of solid tumors, including PM, although some limitations are related to pharmacokinetic aspects. The use of PTX-loaded MSCs to treat PM should provide several potential advantages over the systemically administered drug as reduced toxicity and increased concentration of active drug in the tumor-surrounding context. The PACLIMES trial explores the safety and toxicity of the local administration of Paclimes in chemonaive patients, candidates for pleurectomy. The secondary objective is to find the effective Paclimes dose for subsequent phase II studies and to observe and record the antitumor activity. <b>Future direction</b>. The experimental pre-clinical background and rationale are discussed as well.

CancersVol. 16(19)
University of Milan (IT), University of Pavia (IT), Istituti Clinici Scientifici Maugeri (IT), Policlinico San Matteo Fondazione (IT), Istituti di Ricovero e Cura a Carattere Scientifico (IT), Fondazione IRCCS Istituto Neurologico Carlo Besta (IT)
Fondazione Regionale per la Ricerca Biomedica
Good health and well-being
Openalex Percentile: Top 24%
Occupational and environmental lung diseases
0.84
DOIOpen Access PDFOpenAlex
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