Dendritic Cell-based Immunotherapy in Mesothelioma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00280982|
Recruitment Status : Completed
First Posted : January 24, 2006
Last Update Posted : November 16, 2010
|Condition or disease||Intervention/treatment||Phase|
|Malignant Pleural Mesothelioma||Biological: tumor lysate-loaded autologous dendritic cells||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Vaccination With Autologous Dendritic Cells Pulsed With Tumor Lysate for Treatment of Patients With Malignant Pleural Mesothelioma|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2009|
Biological: tumor lysate-loaded autologous dendritic cells
- safety [ Time Frame: april 2008 ]
- tolerability [ Time Frame: april 2008 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00280982
|Department of Pulmonary Medicine|
|Rotterdam, Zuid-Holland, Netherlands, 3015 GE|
|Principal Investigator:||Joachim G Aerts, MD, PhD||Erasmus Medical Center|