CompletedPhase 1/2

Dendritic Cell Vaccination for Patients with Solid Tumors

Belgium48 participantsStarted 2010-05-03

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Tumor type:
✓. Extent of disease:
✓. Patient Characteristics

Exclusion criteria

✕. Subjects with concurrent additional malignancy (with exception of non-melanoma skin cancers and carcinoma in situ of the cervix)
✕. Subjects who are pregnant
✕. Subjects who have sensitivity to drugs that provide local anesthesia
✕. Subjects needing corticosteroids 1 mg/kg during vaccination; corticosteroids are allowed as part of their treatment when taken ≥ 30 days before the start of vaccination.

What they're measuring

Immunogenicity of intradermal DC vaccination

Timeframe: up to 2 months

Trial details

NCT IDNCT01291420

SponsorUniversity Hospital, Antwerp

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-04-25

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