First step results from a phase II study of a dendritic cell vaccine in glioblastoma patients (CombiG-vax).

ABSTRACT:

Background

Glioblastoma (GBM) is a poor prognosis grade 4 glioma. After surgical resection, the standard therapy consists of concurrent radiotherapy (RT) and temozolomide (TMZ) followed by TMZ alone. Our previous data on melanoma patients showed that Dendritic Cell vaccination (DCvax) could increase the amount of intratumoral-activated cytotoxic T lymphocytes.

Methods

This is a single-arm, monocentric, phase II trial in two steps according to Simon's design. The trial aims to evaluate progression-free survival (PFS) at three months and the safety of a DCvax integrated with standard therapy in resected GBM patients. DCvax administration begins after completion of RT-CTwith weekly administrations for 4 weeks, then is alternated monthly with TMZ cycles. The primary endpoints ar

SUBMITTER: Ridolfi L 

PROVIDER: S-EPMC11347333 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature