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Autologous Dendritic Cell Vaccination in Mesothelioma

NCT02649829 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-04-29

No results posted yet for this study

Summary

In this multicenter phase I/II trial, dendritic cells (DCs) loaded with the mesothelioma-associated tumor antigen WT1 will be used in conjunction with conventional chemotherapy for the frontline treatment of malignant pleural mesothelioma (MPM). The general objective is to provide the first-in-human experimental demonstration that the combination of platinum/pemetrexed-based chemotherapy with WT1-targeted DC vaccination is feasible and safe and enables the induction of both systemic and in situ mesothelioma-specific immune responses in patients with MPM.

Conditions

  • Malignant Pleural Mesothelioma

Interventions

BIOLOGICAL

dendritic cell vaccination plus chemotherapy

A. Chemoimmunotherapy: 1. four 3-weekly cycles of platinum/pemetrexed; on day 1 of each cycle, pemetrexed 500 mg/m2 should be administered as intravenous (IV) infusion over 10 minutes followed 30 minutes later by cisplatin 75 mg/m2 as IV over approximately 2 hours. 2. four intradermal vaccinations with 8-10 x 10e6 autologous WT1 mRNA-loaded DCs; at day 14+/- 3 days after the start of each chemotherapy cycle. B. Surgery: pleurectomy/decortication; in case of resectable disease, 4-6 weeks after start of the last chemotherapy cycle.

Sponsors & Collaborators

  • Kom Op Tegen Kanker

    collaborator OTHER

  • Stichting tegen Kanker

    collaborator OTHER

  • University Hospital, Antwerp

    lead OTHER

Principal Investigators

  • Zwi N Berneman, MD, PhD · Antwerp University Hospital, Division of Hematology and Center for Cell Therapy and Regenerative Medicine

  • Eva Lion, MSc, PhD · University of Antwerp, Laboratory of Experimental Hematology

  • Evelien LJ Smits, MSc, PhD · University of Antwerp, Laboratory of Experimental Hematology

  • Sébastien Anguille, MD, PhD · Antwerp University Hospital, Division of Hematology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-03
Primary Completion
2025-03-09
Completion
2025-03-09

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02649829 on ClinicalTrials.gov