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
. 2010 Apr;12(4):401-8.
doi: 10.1093/neuonc/nop047. Epub 2010 Jan 25.

Intracerebral administration of CpG oligonucleotide for patients with recurrent glioblastoma: a phase II study

Alexandre Carpentier  1 , Philippe Metellus, Renata Ursu, Sarah Zohar, Francois Lafitte, Maryline Barrié, Yuxia Meng, Margaretha Richard, Christophe Parizot, Florence Laigle-Donadey, Guy Gorochov, Dimitri Psimaras, Marc Sanson, Annick Tibi, Olivier Chinot, Antoine F Carpentier
Affiliations
Clinical Trial

Intracerebral administration of CpG oligonucleotide for patients with recurrent glioblastoma: a phase II study

Alexandre Carpentier et al. Neuro Oncol. 2010 Apr.

Abstract

Immunostimulating oligodeoxynucleotides containing CpG motifs (CpG-ODN) have shown promising efficacy in cancer models when injected locally. In a phase I clinical trial, intratumoral infusions of CpG-ODN in glioblastoma (GBM) patients were well tolerated at doses up to 20 mg. This phase II trial was designed to study the efficacy of a local treatment by CpG-ODN in patients with recurrent GBMs. Patients with recurrent GBM occurring at least 3 months after radiotherapy, and previously treated with 1 or 2 regimens of chemotherapy received 20 mg of CpG-ODN (CpG-28) by convection-enhanced delivery. The primary endpoint was the percentage of patients without tumor progression 6 months after inclusion. Secondary endpoints were tolerance, survival, and radiological response. Thirty-four patients were enrolled in two centers between November 2004 and March 2006. Thirty-one patients received CpG-ODN treatment. The progression-free survival (PFS) at 6 months was 19%. One partial response and 3 minor responses were observed. The median overall survival was 28 weeks. Eight patients (24%) were alive 1 year after inclusion and 5 patients (15%) were alive after 2 years. Treatment was usually well tolerated. As reported previously, the most common toxicities were lymphopenia, mild fever, seizures, and transient neurological worsening. Despite a few cases showing a radiological response, CpG-28 showed modest activity on the 6-month PFS in this patient population. The molecular or clinical characteristics of a subgroup of patients that could potentially benefit from such an approach remain to be defined.

PubMed Disclaimer

Figures

Fig. 1.
Fig. 1.
PFS in the treated population (with 95% confidence interval in dashed lines).
Fig. 2.
Fig. 2.
OS in the intent-to-treat population (with 95% confidence interval in dashed lines).
Fig. 3.
Fig. 3.
PKs in 6 patients after intracerebral infusion of CpG-28 in logarithmic scale (each line represents 1 patient).
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Stupp R, Mason WP, van den Bent MJ, et al. European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005;352:987–996. - PubMed
    1. Yung WK, Albright RE, Olson J, et al. A phase II study of temozolomide vs. procarbazine in patients with glioblastoma multiforme at first relapse. Br J Cancer. 2000;83:588–593. - PMC - PubMed
    1. Lamborn KR, Yung WK, Chang SM, et al. North American Brain Tumor Consortium. Progression-free survival: an important end point in evaluating therapy for recurrent high-grade gliomas. Neuro-Oncology. 2008;10:162–170. - PMC - PubMed
    1. Krieg AM. Antitumor applications of stimulating toll-like receptor 9 with CpG oligodeoxynucleotides. Curr Oncol Rep. 2004;6:88–95. - PubMed
    1. Takeshita F, Leifer CA, Gursel I, et al. Cutting edge: role of Toll-like receptor 9 in CpG DNA-induced activation of human cells. J Immunol. 2001;167:3555–3558. - PubMed

Publication types

MeSH terms

Substances