NCT01291420

Dendritic Cell Vaccination for Patients with Solid Tumors

Therapeutic Efficacy of Wilms' Tumor Gene (WT1) MRNA-electroporated Autologous Dendritic Cell Vaccination in Patients with Solid Tumors: a Phase I/feasibility Study

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: University Hospital, Antwerp · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the immunogenicity and clinical efficacy of intradermal vaccination with autologous RNA-modified dendritic cells (DCs) - engineered to express the WT1 protein - in patients with limited spread metastatic solid tumors, i.e. breast cancers, glioblastoma grade IV, sarcomas, malignant mesothelioma and colorectal tumors. Based on the results of our previously performed phase I study with autologous WT1 mRNA-transfected DC, the investigators hypothesize that the vaccination with DC will be well-tolerated and will result in an increase in WT1-specific CD8+ T cell responses.

Conditions

• Glioblastoma
• Renal Cell Carcinoma
• Sarcomas
• Breast Cancers
• Malignant Mesothelioma
• Colorectal Tumors

Interventions

Type	Name	Description
BIOLOGICAL	autologous dendritic cell vaccination	4 biweekly intradermal DC injections of 10\*10E6 DCs (500 µL) at 5 sites (100 µL/site) in the ventromedial regions of the upper arm approximately 5-10 cm of the regional lymph nodes

Timeline

• Start date: 2010-05-03
• Primary completion: 2016-04-25
• Completion: 2017-11-02
• First posted: 2011-02-08
• Last updated: 2024-12-09

Locations

1 site across 1 country: Belgium