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| Sponsor: | Erasmus Medical Center |
|---|---|
| Information provided by: | Erasmus Medical Center |
| ClinicalTrials.gov Identifier: | NCT00280982 |
Purpose
Exploiting the immunostimulatory capacities of dendritic cells holds great promise for cancer immunotherapy. A mouse model for malignant mesothelioma allowed us to prove that autologous dendritic cells presenting tumor antigens were very effective by (partly) inhibiting tumor growth. This study will test the feasibility and safety of a clinical trial using autologous DC as a therapeutic adjuvant for the treatment of malignant pleural mesothelioma.
| Condition | Intervention | Phase |
|---|---|---|
|
Malignant Pleural Mesothelioma |
Biological: tumor lysate-loaded autologous dendritic cells |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | Vaccination With Autologous Dendritic Cells Pulsed With Tumor Lysate for Treatment of Patients With Malignant Pleural Mesothelioma |
| Enrollment: | 10 |
| Study Start Date: | January 2006 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Netherlands, Zuid-Holland | |
| Department of Pulmonary Medicine | |
| Rotterdam, Zuid-Holland, Netherlands, 3015 GE | |
| Principal Investigator: | Joachim G Aerts, MD, PhD | Erasmus Medical Center |
More Information
| Responsible Party: | Pulmonary Medicine ( Erasmus MC ) |
| Study ID Numbers: | MEC-2005-269, PMR-MM05-001 |
| Study First Received: | January 20, 2006 |
| Last Updated: | October 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00280982 History of Changes |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
|
dendritic cells, immunotherapy, vaccination, mesothelioma |
|
Neoplasms Neoplasms by Histologic Type Neoplasms, Mesothelial |
Mesothelioma Adenoma Neoplasms, Glandular and Epithelial |