Phase I clinical trial testing the dose escalation and expansion of Pressurized IntraThoracic Hyperthermic Aerosol Cisplatin administration (PITHAC) for the management of pleural carcinosis
Background: Pleural carcinosis originates from various cancers. Its management consists in systemic therapies combined to dyspnea relief procedures. Prior studies have tested hyperthermic intrathoracic chemotherapy to treat pleural carcinosis with interesting patient survival results. However, these...
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Elsevier
2024-01-01
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| Series: | Cancer Treatment and Research Communications |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2468294224000704 |
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| author | Louis-Emmanuel Chriqui Etienne Abdelnour-Berchtold Edoardo Zanfrini Severine Devesa-Perez Michel Gonzalez Thorsten Krueger Kim Ellefsen Alice Destaillats David Bonnet Martin Hübner Hasna Bouchaab Michal Bassani-Sternberg Solange Peters Sabrina Cavin Jean Y Perentes |
| author_facet | Louis-Emmanuel Chriqui Etienne Abdelnour-Berchtold Edoardo Zanfrini Severine Devesa-Perez Michel Gonzalez Thorsten Krueger Kim Ellefsen Alice Destaillats David Bonnet Martin Hübner Hasna Bouchaab Michal Bassani-Sternberg Solange Peters Sabrina Cavin Jean Y Perentes |
| author_sort | Louis-Emmanuel Chriqui |
| collection | DOAJ |
| description | Background: Pleural carcinosis originates from various cancers. Its management consists in systemic therapies combined to dyspnea relief procedures. Prior studies have tested hyperthermic intrathoracic chemotherapy to treat pleural carcinosis with interesting patient survival results. However, these approaches were limited by local toxicity. Pre-clinical data have shown that hyperthermia combined to local pleural chemotherapy increased the immune response against tumors. Recently, pressurized intraperitoneal aerosol chemotherapies (PIPAC) showed improved cytostatic penetration in abdominal carcinosis with a 10-fold-lower chemotherapy dose and minimal side-effects. This approach was also tested in limited numbers of patients with pleural carcinosis but never combined with hyperthermia. Methods: Pressurized IntraThoracic Hyperthermic Aerosol Cisplatin (PITHAC) is an open-label dose-escalation phase I trial. Patients with pleural carcinosis, eligible for the surgical management of their pleural effusion can be enrolled. Cisplatin (7.5–12–5–35–70 mg/m2) heated at 39±1 °C is delivered into the thoracic cavity before the surgical effusion management. Initially, the study consists in a dose escalation of the four different cisplatin doses. The primary endpoint is the maximal tolerated dose of cisplatin administered by PITHAC. The secondary and translational endpoints are adverse events and the immune response directed against cancer following PITHAC. There is then an expansion phase at the recommended cisplatin dose on an additional 15 patients with identical outcomes. Discussion: Pressurized intrathoracic delivery of chemotherapy under hyperthermic conditions was never tested so far. We plan to determine the safety of such an approach in patients managed for pleural carcinosis. If proven safe, PITHAC could be combined with systemic immunotherapies for the management of cancer. Trial registration: ClinicalTrials.gov Identifier: NCT06281860 |
| format | Article |
| id | doaj-art-52283edfb8bf4b6cbdce02aa16e052bf |
| institution | Kabale University |
| issn | 2468-2942 |
| language | English |
| publishDate | 2024-01-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Cancer Treatment and Research Communications |
| spelling | doaj-art-52283edfb8bf4b6cbdce02aa16e052bf2025-02-09T05:00:46ZengElsevierCancer Treatment and Research Communications2468-29422024-01-0142100858Phase I clinical trial testing the dose escalation and expansion of Pressurized IntraThoracic Hyperthermic Aerosol Cisplatin administration (PITHAC) for the management of pleural carcinosisLouis-Emmanuel Chriqui0Etienne Abdelnour-Berchtold1Edoardo Zanfrini2Severine Devesa-Perez3Michel Gonzalez4Thorsten Krueger5Kim Ellefsen6Alice Destaillats7David Bonnet8Martin Hübner9Hasna Bouchaab10Michal Bassani-Sternberg11Solange Peters12Sabrina Cavin13Jean Y Perentes14Division of Thoracic Surgery, University Hospital of Lausanne, Rue du Bugnon 46 1011, Lausanne, SwitzerlandDivision of Thoracic Surgery, University Hospital of Lausanne, Rue du Bugnon 46 1011, Lausanne, SwitzerlandDivision of Thoracic Surgery, University Hospital of Lausanne, Rue du Bugnon 46 1011, Lausanne, SwitzerlandDivision of Thoracic Surgery, University Hospital of Lausanne, Rue du Bugnon 46 1011, Lausanne, SwitzerlandDivision of Thoracic Surgery, University Hospital of Lausanne, Rue du Bugnon 46 1011, Lausanne, SwitzerlandDivision of Thoracic Surgery, University Hospital of Lausanne, Rue du Bugnon 46 1011, Lausanne, SwitzerlandSponsor Research Office (SRO, University Hospital of Lausanne, Rue du Bugnon 46 1011, Lausanne, SwitzerlandSponsor Research Office (SRO, University Hospital of Lausanne, Rue du Bugnon 46 1011, Lausanne, SwitzerlandSponsor Research Office (SRO, University Hospital of Lausanne, Rue du Bugnon 46 1011, Lausanne, SwitzerlandDivision of Visceral Surgery, University Hospital of Lausanne, Rue du Bugnon 46 1011, Lausanne, SwitzerlandDivision of Oncology, University Hospital of Lausanne, Rue du Bugnon 46 1011, Lausanne, SwitzerlandLudwig Institute for Cancer Research, Lausanne Branch, Department of Oncology, University of Lausanne (UNIL) and Lausanne University Hospital (CHUV), Agora Cancer Research Center, Lausanne, Switzerland; Center for Cell Therapy, CHUV-Ludwig Institute, Lausanne, SwitzerlandDivision of Oncology, University Hospital of Lausanne, Rue du Bugnon 46 1011, Lausanne, SwitzerlandDivision of Thoracic Surgery, University Hospital of Lausanne, Rue du Bugnon 46 1011, Lausanne, SwitzerlandDivision of Thoracic Surgery, University Hospital of Lausanne, Rue du Bugnon 46 1011, Lausanne, Switzerland; Corresponding author.Background: Pleural carcinosis originates from various cancers. Its management consists in systemic therapies combined to dyspnea relief procedures. Prior studies have tested hyperthermic intrathoracic chemotherapy to treat pleural carcinosis with interesting patient survival results. However, these approaches were limited by local toxicity. Pre-clinical data have shown that hyperthermia combined to local pleural chemotherapy increased the immune response against tumors. Recently, pressurized intraperitoneal aerosol chemotherapies (PIPAC) showed improved cytostatic penetration in abdominal carcinosis with a 10-fold-lower chemotherapy dose and minimal side-effects. This approach was also tested in limited numbers of patients with pleural carcinosis but never combined with hyperthermia. Methods: Pressurized IntraThoracic Hyperthermic Aerosol Cisplatin (PITHAC) is an open-label dose-escalation phase I trial. Patients with pleural carcinosis, eligible for the surgical management of their pleural effusion can be enrolled. Cisplatin (7.5–12–5–35–70 mg/m2) heated at 39±1 °C is delivered into the thoracic cavity before the surgical effusion management. Initially, the study consists in a dose escalation of the four different cisplatin doses. The primary endpoint is the maximal tolerated dose of cisplatin administered by PITHAC. The secondary and translational endpoints are adverse events and the immune response directed against cancer following PITHAC. There is then an expansion phase at the recommended cisplatin dose on an additional 15 patients with identical outcomes. Discussion: Pressurized intrathoracic delivery of chemotherapy under hyperthermic conditions was never tested so far. We plan to determine the safety of such an approach in patients managed for pleural carcinosis. If proven safe, PITHAC could be combined with systemic immunotherapies for the management of cancer. Trial registration: ClinicalTrials.gov Identifier: NCT06281860http://www.sciencedirect.com/science/article/pii/S2468294224000704Pleural carcinosisIntrapleural ChemotherapyHyperthermic chemotherapy |
| spellingShingle | Louis-Emmanuel Chriqui Etienne Abdelnour-Berchtold Edoardo Zanfrini Severine Devesa-Perez Michel Gonzalez Thorsten Krueger Kim Ellefsen Alice Destaillats David Bonnet Martin Hübner Hasna Bouchaab Michal Bassani-Sternberg Solange Peters Sabrina Cavin Jean Y Perentes Phase I clinical trial testing the dose escalation and expansion of Pressurized IntraThoracic Hyperthermic Aerosol Cisplatin administration (PITHAC) for the management of pleural carcinosis Cancer Treatment and Research Communications Pleural carcinosis Intrapleural Chemotherapy Hyperthermic chemotherapy |
| title | Phase I clinical trial testing the dose escalation and expansion of Pressurized IntraThoracic Hyperthermic Aerosol Cisplatin administration (PITHAC) for the management of pleural carcinosis |
| title_full | Phase I clinical trial testing the dose escalation and expansion of Pressurized IntraThoracic Hyperthermic Aerosol Cisplatin administration (PITHAC) for the management of pleural carcinosis |
| title_fullStr | Phase I clinical trial testing the dose escalation and expansion of Pressurized IntraThoracic Hyperthermic Aerosol Cisplatin administration (PITHAC) for the management of pleural carcinosis |
| title_full_unstemmed | Phase I clinical trial testing the dose escalation and expansion of Pressurized IntraThoracic Hyperthermic Aerosol Cisplatin administration (PITHAC) for the management of pleural carcinosis |
| title_short | Phase I clinical trial testing the dose escalation and expansion of Pressurized IntraThoracic Hyperthermic Aerosol Cisplatin administration (PITHAC) for the management of pleural carcinosis |
| title_sort | phase i clinical trial testing the dose escalation and expansion of pressurized intrathoracic hyperthermic aerosol cisplatin administration pithac for the management of pleural carcinosis |
| topic | Pleural carcinosis Intrapleural Chemotherapy Hyperthermic chemotherapy |
| url | http://www.sciencedirect.com/science/article/pii/S2468294224000704 |
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