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Dendritic Cell-based Immunotherapy in Mesothelioma | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Dendritic Cell-based Immunotherapy in Mesothelioma

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

NCT00280982•Erasmus Medical Center

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with clinically and histological or cytological confirmed newly diagnosed mesothelioma, that can be measured in two dimensions by a radiologic imaging study.
•Patients must be at least 18 years old and must be able to give written informed consent.
•Patients must be ambulatory (Karnofsky scale \> 70, or WHO-ECOG performance status 0,1, or 2) and in stable medical condition. The expected survival must be at least 4 months.
•Patients must have normal organ function and adequate bone marrow reserve: absolute neutrophil count \> 1.5\*109/l, platelet count \> 100\*109/l, and Hb \> 6.0 mmol/l.
•Positive delayed type hypersensitivity skin test (induration \> 2mm after 48hrs) against at least one positive control antigen of MULTITEST CMI (Pasteur merieux).
•Stable disease or response after chemotherapy.
•Availability of sufficient tumor material of the patient.
•Ability to return to the Erasmus MC for adequate follow-up as required by this protocol.

Exclusion Criteria

•Conditions that make the patient unfit for chemotherapy or progressive disease after 4 cycles of chemotherapy.
•Pleurodesis at the affected side before the pleural fluid is obtained.
•Medical or psychological impediment to probable compliance with the protocol.
•Patients on steroid (or other immunosuppressive agents) are excluded on the basis of potential immune suppression. Patients must have had 6 weeks of discontinuation and must stop of any such treatment during the time of the study.
•No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, superficial or in-situ cancer of the bladder or other cancer for which the patient has been disease-free for five years.
•Serious concomitant disease, no active infections. Patients with a history of autoimmune disease or organ allografts, or with active acute or chronic infection, including HIV and viral hepatitis.
•Patients with serious intercurrent chronic or acute illness such as pulmonary (asthma or COPD) or cardiac (NYHA class III or IV) or hepatic disease or other illness considered by the study coordinators to constitute an unwarranted high risk for investigational DC treatment.
•Patients with a known allergy to shell fish (contains KLH).
•Pregnant or lactating women.
•Patients with inadequate peripheral vein access to perform leukapheresis
+3 more criteria

Locations (1)

Department of Pulmonary Medicine

Rotterdam, South Holland, Netherlands

Key Dates

Start Date

January 1, 2006

Primary Completion Date

September 1, 2009

Completion Date

September 1, 2009

Last Updated

November 16, 2010

Enrollment

ACTUAL participants

Conditions

Malignant Pleural Mesothelioma

Interventions

tumor lysate-loaded autologous dendritic cells

BIOLOGICAL

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Malignant Pleural Mesothelioma

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ACTIVE_NOT_RECRUITINGPHASE3

Efficacy & Safety of rAd-IFN Administered With Celecoxib & Gemcitabine in Patients With Malignant Pleural Mesothelioma

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Malignant Pleural Mesothelioma

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TERMINATEDPHASE1

Pembrolizumab and Hypofractionated Stereotactic Radiotherapy in Patients With Malignant Pleural Mesothelioma

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 16, 2010Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Dendritic Cell-based Immunotherapy in Mesothelioma

Inclusion Criteria

Exclusion Criteria

Integration of the PD-L1 Inhibitor Atezolizumab and WT1/DC Vaccination Into Platinum/Pemetrexed-based First-line Treatment for Epithelioid Malignant Pleural Mesothelioma

Efficacy & Safety of rAd-IFN Administered With Celecoxib & Gemcitabine in Patients With Malignant Pleural Mesothelioma

Pembrolizumab and Hypofractionated Stereotactic Radiotherapy in Patients With Malignant Pleural Mesothelioma

Autologous Dendritic Cell Vaccination in Mesothelioma

Effect of HITHOC After Pleurectomy Decortication for Treatment of Malignant Pleural Mesothelioma

Evaluation of the Clinical/Biological Characteristics, Efficacy and Safety of Patients With Malignant Pleural Mesothelioma, Treated by Immunotherapy