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Studieoverzicht

Study name: MESOPEC: Adjuvant dendritic cell based immunotherapy (DCBI) after cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) for peritoneal mesothelioma

Histology Mesothelioma
Host / recruiting site 1 Erasmus MC Enrollment Planned
Therapy line Later line (≥2L)
Design

An open-label single-center phase II study to assess the feasibility of administering DCBI after CRS-HIPEC in patients with MPM.
Intervention

4 to 6 weeks before CRS-HIPEC a leukapheresis is performed of which the monocytes are used for differentiation to dendritic cells (DCs) using specific cytokines. Pulsed autologous DCs (MesoPher) are re-injected 8-10 weeks after surgery, 3 times every two weeks. After the third injection with MesoPher revaccinations to boost the immune system are given after 3 and 6 months.
Key outcome parameters
  • Primary Objective: The main goal of this project is to determine the feasibility of administering DCBI after CRS-HIPEC in patients with malignant peritoneal mesothelioma.
  • Secondary Objective(s): Secondary 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.
Key inclusion criteria
  • Patients with a histologically or cytologically confirmed diagnosis of malignant peritoneal mesothelioma.
  • 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 >100109/l and Hb >6.0mmol/l
  • Ability to return to the study center for adequate follow-up and vaccinations
Key exclusion criteria
  • Extra-abdominal disease/ metastatic disease.
  • 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.
  • Prior cytoreductive surgery.
  • Prior malignancy other than basal cell carcinoma within 10 years of inclusion.
  • 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.
  • Patients with a known allergy to shell fish (may contain KLH).
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