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Adjuvant immunotherapy after surgery for patients with peritoneal mesothelioma


- candidate number28649
- NTR NumberNTR7060
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-feb-2018
- Secondary IDsMEC NL60856.000.17
- Public TitleAdjuvant immunotherapy after surgery for patients with peritoneal mesothelioma
- Scientific TitleAdjuvant dendritic cell based immunotherapy (DCBI) after cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) for peritoneal mesothelioma
- ACRONYMMESOPEC
- hypothesisMalignant peritoneal mesothelioma (MPM) is an uncommon but aggressive neoplasm. MPM has low survival rates of approximately one 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.
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. Objective of this study is to assess the feasibility of administering DCBI after CRS-HIPEC in patients with MPM.
- Healt Condition(s) or Problem(s) studiedMesothelioma , Peritoneal mesothelioma
- Inclusion criteriaIn order to be eligible to participate in this study, a subject must meet all of the following criteria, before undergoing CRS-HIPEC:

• Patients with a histologically or cytologically confirmed diagnosis of malignant peritoneal mesothelioma
• Patients must be at least 18 years old and must be able to give written informed consent
• Patients must be ambulatory (WHO-ECOG performance status 0 or 1) and in stable medical condition
• Patients must have normal organ function and adequate bone marrow reserve: absolute neutrophil count >1.0 *109/l, platelet count >100*109/l and Hb >6.0mmol/l
• Ability to return to the study center for adequate follow-up and vaccinations
• Positive DTH skin test (induration > 2mm after 48 hrs) against at least one positive control antigen tetanus toxoid.
• Written informed consent according to the ICH-GCP
• Planned start date of vaccination within 8-10 weeks after CRS-HIPEC
• The expected survival must be at least 6 months
• Ability to return to the Erasmus MC for adequate follow-up as required by this protocol
- Exclusion criteriaA potential participant who meets any of the following criteria will be excluded from participation in the study:

• Extra-abdominal disease/ metastatic disease
• Medical or psychological impediment to probable compliance with the protocol
• Current use of steroids or other immunosuppressive agents. Patients must have had six weeks of discontinuation before the first vaccination and must stop any such treatment during the time of the study on the basis of potential immune suppression. Prophylactic usage of dexamethasone during chemotherapy is excluded from that 6 weeks interval.
• Prior cytoreductive surgery
• Prior malignancy other than basal cell carcinoma within 10 years of inclusion
• Serious concomitant disease or active infections
• History of auto-immune disease or organ allografts, or with active or chronic infection, including HIV and viral hepatitis
• Serious intercurrent chronic or acute illness such as pulmonary (COPD or asthma) or cardiac (NYHA class III or IV) or hepatic disease or other illness considered by the study coordinator to constitute an unwarranted high risk for CRS-HIPEC or investigational DC treatment
• Pregnant or lactating women
• Inadequate peripheral vein access to perform leukapheresis
• Concomitant participation in another clinical trial
• An organic brain syndrome or other significant psychiatric abnormality which would comprise the ability to give informed consent, and preclude participation in the full protocol and follow-up
• Absence of assurance of compliance with the protocol
• Patients with a known allergy to shell fish (may contain KLH)
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-apr-2018
- planned closingdate1-apr-2020
- Target number of participants20
- InterventionsAdjuvant dendritic cell based immunotherapy; before undergoing CRS-HIPEC a leukapheresis is performed of which the monocytes are used for differentiation to dendritic cells (DCs) using specific cytokines. Pulsed autologous DCs are re-injected after recovery from surgery (8-10 weeks), 3 times every two weeks. After the third injection with DCs revaccinations to boost the immune system are given after 3 and 6 months.
- Primary outcomeThe main goal of this project is to determine the feasibility of administering DCBI after CRS-HIPEC in patients with malignant peritoneal mesothelioma.
- Secondary outcomeSecondary endpoint of this study is to assess safety in patients with peritoneal mesothelioma who are treated with DCBI, which has already been proven in patients with pleural mesothelioma. Another secondary endpoint of this study is the determination of an immunological response against the tumor as result of the adjuvant therapy.
- TimepointsThe end of the study is defined as the last patient’s last visit.
- Trial web sitehttps://www.erasmusmc.nl/kankerinstituut/research/studies-erasmusmc-kanker-instituut/mesopecstudie/
- status[default]
- CONTACT FOR PUBLIC QUERIESMD N.L. de Boer
- CONTACT for SCIENTIFIC QUERIESMD N.L. de Boer
- Sponsor/Initiator Erasmus Medical Center, Rotterdam
- Funding
(Source(s) of Monetary or Material Support)
KWF Kankerbestrijding, Stichting Coolsingel
- Publications
- Brief summaryThe MESOPEC study is a single center, fase II study, that will be performed by the Erasmus MC Cancer Institute. The main goal of this study is to determine the feasibility of adjuvant dendritic cell based immunotherapy after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for patients diagnosed with peritoneal mesothelioma.
- Main changes (audit trail)
- RECORD27-feb-2018 - 25-mrt-2018


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