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

Autor: Stella GM; Department of Internal Medicine and Medical Therapeutics, University of Pavia Medical School, 27100 Pavia, Italy.; Unit of Respiratory Diseases, Cardiothoracic and Vascular Department, IRCCS Policlinico San Matteo, 27100 Pavia, Italy., Lisini D; Cell Therapy Production Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, 20133 Milan, Italy., Pedrazzoli P; Department of Internal Medicine and Medical Therapeutics, University of Pavia Medical School, 27100 Pavia, Italy.; Medical Oncology Unit, Oncology and Hematology Department, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy., Galli G; Department of Internal Medicine and Medical Therapeutics, University of Pavia Medical School, 27100 Pavia, Italy.; Medical Oncology Unit, Oncology and Hematology Department, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy., Bortolotto C; Diagnostic Imaging Unit, Department of Clinical, Surgical, Diagnostic, and Pediatric Sciences, University of Pavia, 27100 Pavia, Italy.; Radiology Unit-Diagnostic Imaging I, Department of Diagnostic Medicine, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy., Melloni G; Unit of Thoracic Surgery, Cardiothoracic and Vascular Department, IRCCS Policlinico San Matteo, 27100 Pavia, Italy., D'Ambrosio G; Pathology Unit, Department of Diagnostical Services and Imaging, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy., Klersy C; Biostatistics and Clinical Trial Center, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, 27100 Pavia, Italy., Grosso A; Unit of Respiratory Diseases, Cardiothoracic and Vascular Department, IRCCS Policlinico San Matteo, 27100 Pavia, Italy., Paino F; CRC StaMeTec, Department of Biomedical, Surgical and Dental Sciences, University of Milan, 20122 Milan, Italy., Tomaselli S; Unit of Respiratory Diseases, Cardiothoracic and Vascular Department, IRCCS Policlinico San Matteo, 27100 Pavia, Italy., Saracino L; Unit of Respiratory Diseases, Cardiothoracic and Vascular Department, IRCCS Policlinico San Matteo, 27100 Pavia, Italy., Alessandri G; CRC StaMeTec, Department of Biomedical, Surgical and Dental Sciences, University of Milan, 20122 Milan, Italy., Pessina A; CRC StaMeTec, Department of Biomedical, Surgical and Dental Sciences, University of Milan, 20122 Milan, Italy., Grignani E; Environmental Research Center, Istituti Clinici Scientifici Maugeri IRCCS, 27100 Pavia, Italy., Rosti V; Phase 1 Clinical Trial Unit and Experimental Therapy, IRCCS Policlinico San Matteo, 27100 Pavia, Italy., Corsico AG; Department of Internal Medicine and Medical Therapeutics, University of Pavia Medical School, 27100 Pavia, Italy.; Unit of Respiratory Diseases, Cardiothoracic and Vascular Department, IRCCS Policlinico San Matteo, 27100 Pavia, Italy., Comoli P; Cell Factory, Pediatric Hematology/Oncology, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy., Agustoni F; Department of Internal Medicine and Medical Therapeutics, University of Pavia Medical School, 27100 Pavia, Italy.; Medical Oncology Unit, Oncology and Hematology Department, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy.
Jazyk: angličtina
Zdroj: Cancers [Cancers (Basel)] 2024 Oct 04; Vol. 16 (19). Date of Electronic Publication: 2024 Oct 04.
DOI: 10.3390/cancers16193391
Abstrakt: Background and rationale. 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. Study design. 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. Future direction . The experimental pre-clinical background and rationale are discussed as well.
Databáze: MEDLINE
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