asbestos cancer malignant pleural mesothelioma
Conditions
Interventions
Before standard-of-care chemotherapy, a leukapheresis will be performed and
monocytes will be collected for the production of DCT. Allogeneic tumor lysate
(Pheralys) loaded autologous DCs (MesoPher)
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Patients with a histologically confirmed diagnosis of epithelioid MPM who are eligible for 2 to 4 cycles of platinum-based chemotherapy. • Patients must be at least 18 years old and must be able to give written informed consent. • ECOG performance status 0-1. • Written informed consent according to ICH-GCP. •Fit to receive platinum-based chemotherapy (as per standard of care of the treating physician/Institution) and undergo a P/D with optional removal of hemidiaphragm and pericardium. The responsible surgeon and chest physician should judge the required fitness prior to registration, taking into account the results of all the relevant (i.e. pulmonary, cardiac) examinations. • Tumor tissue available after completing chemotherapy and before starting treatment with DCT. Tumor tissue can be obtained by either a CT-guided needle biopsy or a VATS surgical biopsy.
Exclusion criteria
Exclusion criteria: • Clinical or radiological invasion of mediastinal structures (heart, aorta, spine, esophagus, etc.) and widespread chest wall invasion (stage T4). Involvement of supraclavicular or coeliac nodes. Stage IV (metastatic disease). • Subject with any concurrent medical, psychological or psychiatric disease or condition that is likely to compromise the ability to give informed consent or to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study. • 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. • Subject with any known active serious infection, including human immunodeficiency virus (HIV), hepatitis B or C virus, or syphilis infection. • Subject with a history of autoimmune disease, except for diabetes mellitus type I or other conditions, where patient can be eligible following discussion with medical monitor. • Subject who has received an organ allograft. • 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 eP/D or investigational DCT. •Unavailability of tumor tissue after completing chemotherapy and before starting treatment with DCT.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the feasibility of DCT performed before and after eP/D in patients with early stage epithelioid MPM who received first line chemotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety of DCT performed before and after eP/D in patients with early stage epithelioid MPM. To evaluate the efficacy (as measured by progression free and overall survival) of combining DCT and eP/D after chemotherapy in patients with early stage epithelioid MPM. To determine the anti-tumor immune response induced by (neo)adjuvant DCT. | — |
Countries
Netherlands
Outcome results
None listed