asbestos cancer peritoneal mesenthelioma
Conditions
Interventions
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
immunotherapy
malignant peritoneal mesothelioma
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Patients with a histologically 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 criteria
Exclusion criteria: 4.3 Exclusion criteria A 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 • Subject with any previous malignancy except adequately treated basal cell or squamous cell skin cancer, superficial or in-situ cancer of the bladder or other cancer for which the subject has been disease-free for at least 3 years or a malignancy that requires no active treatment. • 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim of this phase II study is to determine the feasibility of adjuvant DCBI with injection of MesoPher in patients with MPM after CRS-HIPEC. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint of this study is safety of this therapy, which has already been proven in patients with pleural mesothelioma. Another secondary endpoint is the determination of an immunological response against the tumor as result of the adjuvant therapy. | — |
Countries
The Netherlands
Outcome results
None listed