NCT00280982

Dendritic Cell-based Immunotherapy in Mesothelioma

Vaccination With Autologous Dendritic Cells Pulsed With Tumor Lysate for Treatment of Patients With Malignant Pleural Mesothelioma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Malignant Pleural Mesothelioma

Interventions

Type	Name	Description
BIOLOGICAL	tumor lysate-loaded autologous dendritic cells	50x10e6 cells per vaccination, 3 times, 2 weeks interval

Timeline

• Start date: 2006-01-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2006-01-24
• Last updated: 2010-11-16

Locations

1 site across 1 country: Netherlands