Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2024 Aug 13:15:1404861.
doi: 10.3389/fimmu.2024.1404861. eCollection 2024.

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

Laura Ridolfi  1 , Lorena Gurrieri  1 , Nada Riva  1 , Jenny Bulgarelli  1 , Francesco De Rosa  1 , Massimo Guidoboni  1 , Valentina Fausti  1 , Nicoletta Ranallo  1 , Sebastiano Calpona  1 , Marcella Tazzari  1 , Massimiliano Petrini  1 , Anna Maria Granato  1 , Elena Pancisi  1 , Flavia Foca  2 , Monia Dall'Agata  2 , Isabella Bondi  2 , Elena Amadori  3 , Pietro Cortesi  4 , Chiara Zani  5 , Valentina Ancarani  1 , Alessandro Gamboni  6 , Antonio Polselli  7 , Giuseppe Pasini  8 , Daniela Bartolini  9 , Giuseppe Maimone  10 , Donatella Arpa  11 , Luigino Tosatto  10
Affiliations
Clinical Trial

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

Laura Ridolfi et al. Front Immunol. .

Erratum in

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 are PFS at three months and safety. One of the secondary objectives is to evaluate the immune response both in vitro and in vivo (DTH skin test).

Results: By December 2022, the first pre-planned step of the study was concluded with the enrollment, treatment and follow up of 9 evaluable patients. Two patients had progressed within three months after leukapheresis, but none had experienced DCvax-related G3-4 toxicities Five patients experienced a positive DTH test towards KLH and one of these also towards autologous tumor homogenate. The median PFS from leukapheresis was 11.3 months and 12.2 months from surgery.

Conclusions: This combination therapy is well-tolerated, and the two endpoints required for the first step have been achieved. Therefore, the study will proceed to enroll the remaining 19 patients. (Eudract number: 2020-003755-15 https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-003755-15/IT).

Keywords: adoptive cell therapy; dendritic cell; glioblastoma; immunotherapy; radiochemotherapy; vaccine.

PubMed Disclaimer

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision.

Figures

Figure 1
Figure 1
(A) Study Schema: pre-screening phase of 28 days, screening phase of 7 days during which the baseline DTH skin test is performed, induction phase of 4 weeks, and maintenance phase lasting up to 11 months. (B) Consort Flow Diagram summarizing screening failures.
See this image and copyright information in PMC

References

    1. Stupp R, Mason ,WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, et al. . Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. (2005) 352:987–96. doi: 10.1056/NEJMoa043330 - DOI - PubMed
    1. Sevastre AS, Costachi A, Tataranu LG, Brandusa C, Artene SA, Stovicek O, et al. . Glioblastoma pharmacotherapy: A multifaceted perspective of conventional and emerging treatments (Review). Exp Ther Med. (2021) 22:1408. doi: 10.3892/etm.2021.10844 - DOI - PMC - PubMed
    1. Kurz SC, Wen PY. Quo vadis-do immunotherapies have a role in glioblastoma? Curr Treat Options Neurol. (2018) 20:14. doi: 10.1007/s11940-018-0499-0 - DOI - PubMed
    1. Di Nunno V, Franceschi E, Tosoni A, Gatto L, Bartolini S, Brandes AA. Glioblastoma microenvironment: from an inviolable defense to a therapeutic chance. Front Oncol. (2022) 12:852950. doi: 10.3389/fonc.2022.852950 - DOI - PMC - PubMed
    1. Rodríguez Pérez Á, Campillo-Davo D, Van Tendeloo VFI, Benítez-Ribas D. Cellular immunotherapy: a clinical state-of-the-art of a new paradigm for cancer treatment. Clin Transl Oncol. (2020) 22(11):1923–37. doi: 10.1007/s12094-020-02344-4 - DOI - PubMed

Publication types

MeSH terms

LinkOut - more resources