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Clinical Trial
. 2014 Jan;16(2):274-9.
doi: 10.1093/neuonc/not203. Epub 2013 Dec 12.

Heat-shock Protein Peptide complex-96 Vaccination for Recurrent Glioblastoma: A Phase II, Single-Arm Trial

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Free PMC article
Clinical Trial

Heat-shock Protein Peptide complex-96 Vaccination for Recurrent Glioblastoma: A Phase II, Single-Arm Trial

Orin Bloch et al. Neuro Oncol. .
Free PMC article

Abstract

Background: Outcomes for patients with recurrent glioblastoma multiforme (GBM) are poor and may be improved by immunotherapy. We investigated the safety and efficacy of an autologous heat-shock protein peptide complex-96 (HSPPC-96) vaccine for patients with recurrent GBM.

Methods: In this open-label, single-arm, phase II study, adult patients with surgically resectable recurrent GBM were given vaccine after gross total resection. The primary endpoint was overall survival at 6 months. Secondary endpoints included overall survival, progression-free survival, safety, and immune profiling. Outcome analyses were performed in the intention-to-treat and efficacy populations.

Results: Between October 3, 2007 and October 24, 2011, 41 patients underwent gross total resection of recurrent GBM and received a median of 6 doses of HSPPC-96 vaccine. Following treatment, 90.2% of patients were alive at 6 months (95% confidence interval [CI]: 75.9-96.8) and 29.3% were alive at 12 months (95% CI: 16.6-45.7). Median overall survival was 42.6 weeks (95% CI: 34.7-50.5). Twenty-seven (66%) patients were lymphopenic prior to therapy, and patients with lymphocyte counts below the cohort median demonstrated decreased overall survival (hazard ratio: 4.0; 95% CI: 1.4-11.8; P = .012). There were no treatment-related deaths. There were 37 serious (grades 3-5) adverse events reported, with 17 attributable to surgical resection and a single grade 3 constitutional event related to the vaccine.

Conclusion: The HSPPC-96 vaccine is safe and warrants further study of efficacy for the treatment of recurrent GBM. Significant pretreatment lymphopenia may impact the outcomes of immunotherapy and deserves additional investigation.

Keywords: glioblastoma; heat-shock proteins; immunotherapy.

Figures

Fig. 1.
Fig. 1.
(A) Kaplan–Meier estimates of PFS in 41 patients receiving the HSPPC-96 vaccine for recurrent GBM. Vertical lines indicate the timepoints at which patients were censored. (B) Kaplan–Meier estimates of OS in 41 patients receiving the HSPPC-96 vaccine for recurrent GBM. Vertical lines indicate the timepoints at which patients were censored.
Fig. 2.
Fig. 2.
Kaplan–Meier estimates of OS in 41 patients receiving the HSPPC-96 vaccine for recurrent GBM stratified by ALC relative to median expression. Vertical lines indicate the timepoints at which patients were censored.

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