Vaccination With Autologous Dendritic Cells Pulsed With Tumor Lysate for Treatment of Patients With Malignant Pleural Mesothelioma
For this phase I study, patients with end-stage malignant mesothelioma and who are deemed to
be fit enough to be treated with chemotherapy will be asked to participate in this study.
Patients will first be treated with 4 courses of chemotherapy (standard
treatment[Alimta/cisplatin]). After this chemotherapy a leukapherese is performed of which
the monocytes are used for differentiation to dendritic cells. The procedure to grow these
dendritic cells in vitro (culture) and pulse them with tumor lysate is performed in a
cleanroom environment. Several quality control tests will be performed before the dendritic
cells are ready for re-injection. Three doses of properly pulsed autologous dendritic cells
are then re-injected every two weeks.
Using the proper procedure in mesothelioma patients, minor side effects are expected.
Ten (10) patients will be treated by this procedure to define the safety and toxicity of
immunization and to observe (anti-tumor) immune responses.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Joachim G Aerts, MD, PhD
Erasmus Medical Center
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)