Dendritic Cells Loaded With Allogeneous Cell Lysate in Mesothelioma Patients (MesoCancerVa)

This is an interventional treatment trial for Mesothelioma focused on measuring Dendritic cell-based immunotherapy Read More

Inclusion criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

• Patients with histological or cytological confirmed diagnosed ,malignant mesothelioma, who are non progressive after at least 4 cycles of cisplatin and pemetrexed containing chemotherapy (as determined by CT scanning).
• Measurable disease on CT scanning in two dimensions by a radiologic imaging study.
• Patients must be at least 18 years old and must be able to give written informed consent.
• Patients must be ambulatory (WHO performance status 0,1, or 2 [Appendix E&F]) The expected survival must be at least 3 months.
• Patients must have normal organ function and adequate bone marrow reserve: absolute neutrophil count > 1.0 x 10e9/l, platelet count > 100 x 10e9/l, and Hb > 6.0 mmol/l.(as determined during screening
• Positive delayed type hypersensitivity skin test (induration > 2mm after 48 hrs) against at least one positive control antigen tetanus toxoid.
• Ability to return to the Erasmus Medical Center for adequate follow-up as required by this protocol.
• Written informed consent according to good clinical practice
• Planned start date of vaccination between 5 weeks after the last dosage of chemotherapy

Exclusion criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

• Medical or psychological impediment to probable compliance with the protocol.
• Current use of steroids (or other immunosuppressive agents). Patients must have had 6 weeks of discontinuation and must stop of any such treatment during the time of the study. Prophylactic usage of dexamethasone during chemotherapy is excluded from that 6 weeks interval
• Prior 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 patient has been disease-free for five years.
• Serious concomitant disease, or active infections.
• History of autoimmune disease or organ allografts, or with active acute or chronic infection, including HIV and viral hepatitis.
• Serious intercurrent chronic or acute illness such as pulmonary (asthma or COPD) 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 investigational DC treatment.
• Known allergy to shell fish (may contain KLH).
• 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. Lack of availability for follow-up assessment.