Dendritic Cell Vaccination for Patients with Solid Tumors
NCT01291420 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2024-12-09
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
- 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
Sponsors & Collaborators
-
University Hospital, Antwerp
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-05-03
- Primary Completion
- 2016-04-25
- Completion
- 2017-11-02
Countries
- Belgium
Study Locations
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