Dendritic Cell-based Immunotherapy in Mesothelioma
|Malignant Pleural Mesothelioma||Biological: tumor lysate-loaded autologous dendritic cells||Phase 1|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Vaccination With Autologous Dendritic Cells Pulsed With Tumor Lysate for Treatment of Patients With Malignant Pleural Mesothelioma|
- safety [ Time Frame: april 2008 ]
- tolerability [ Time Frame: april 2008 ]
|Study Start Date:||January 2006|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Biological: tumor lysate-loaded autologous dendritic cells
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00280982
|Department of Pulmonary Medicine|
|Rotterdam, Zuid-Holland, Netherlands, 3015 GE|
|Principal Investigator:||Joachim G Aerts, MD, PhD||Erasmus Medical Center|