Adjuvant dendritic cell based immunotherapy (DCBI) after cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) for peritoneal mesothelioma, a phase II single centre open-label clinical trial: rationale and design of the MESOPEC trial
| Autor: | Joachim G.J.V. Aerts, Nadine L. de Boer, Jacobus W. A. Burger, Cornelis Verhoef, Job P. van Kooten, Eva V. E. Madsen |
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| Přispěvatelé: | Surgery, Pulmonary Medicine |
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Oncology
Adult Male Mesothelioma medicine.medical_specialty Lung Neoplasms medicine.medical_treatment Phases of clinical research Cancer Vaccines 03 medical and health sciences 0302 clinical medicine Clinical Trials Phase II as Topic Adjuvants Immunologic Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Protocol Neoplasm Humans cytoreductive surgery and hyperthermic intraperitoneal chemotherapy dendritic cell based immunotherapy Peritoneal Neoplasms business.industry Mesothelioma Malignant General Medicine Immunotherapy Leukapheresis Cytoreduction Surgical Procedures Dendritic Cells Hyperthermia Induced Middle Aged medicine.disease 3. Good health Clinical trial malignant peritoneal mesothelioma Treatment Outcome 030220 oncology & carcinogenesis Peritoneal mesothelioma Feasibility Studies Hyperthermic intraperitoneal chemotherapy Female business Adjuvant 030215 immunology |
| Zdroj: | BMJ Open BMJ Open, 9(5):e026779. BMJ Publishing Group |
| ISSN: | 2044-6055 |
| Popis: | IntroductionMalignant peritoneal mesothelioma (MPM) is an uncommon but aggressive neoplasm and has a strong association with asbestos exposure. MPM has low survival rates of approximately 1 year even after (palliative) surgery and/or systemic chemotherapy. Recent advances in treatment strategies focusing on cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) have resulted in improved median survival of 53 months and a 5 year survival of 47%. However, recurrence rates are high. Current systemic chemotherapy in the adjuvant setting is of limited efficacy, while immunotherapy with dendritic cell based immunotherapy (DCBI) has yielded promising results in murine models with peritoneal mesothelioma and in patients with pleural mesothelioma.Methods and analysisThe MESOPEC trial is an open-label single centre phase II study. The study population are adult patients with histological/cytological confirmed diagnosis of epithelioid malignant peritoneal mesothelioma. Intervention: 4 to 6 weeks before CRS-HIPEC a leukapheresis is performed of which the monocytes are used for differentiation to dendritic cells (DCs). Autologous DCs pulsed with allogeneic tumour associated antigens (MesoPher) are re-injected 8 to 10 weeks after surgery, three times biweekly. Additional booster vaccinations are given at 3 and 6 months.Primary objective is to determine the feasibility of administering DCBI after CRS-HIPEC in patients with malignant peritoneal mesothelioma. Secondary objectives are to assess safety of DCBI in patients with peritoneal mesothelioma and determine whether a specific immunological response against the tumour occurs as a result of this adjuvant immunotherapy.Ethics and disseminationPermission to carry out this study protocol has been granted by the Central Committee on Research Involving Human Subjects (CCMO in Dutch) and the Research Ethics Committee (METC in Dutch). The results of this trial will be submitted for publication in a peer-reviewed journal.Trial registration numberNTR7060. EudraCT: 2017-000897-12; Pre-Results. |
| Databáze: | OpenAIRE |
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