Heat-shock protein peptide complex-96 vaccination for recurrent glioblastoma: A phase II, single-arm trial

Orin Bloch, Courtney A. Crane, Yelena Fuks, Rajwant Kaur, Manish K. Aghi, Mitchel S. Berger, Nicholas A. Butowski, Susan M. Chang, Jennifer L. Clarke, Michael W. McDermott, Michael D. Prados, Andrew E. Sloan, Jeffrey N. Bruce, Andrew T. Parsa

Research output: Contribution to journalArticle

102 Scopus citations

Abstract

BackgroundOutcomes 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.MethodsIn 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.ResultsBetween 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.ConclusionThe 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.

Original languageEnglish (US)
Pages (from-to)274-279
Number of pages6
JournalNeuro-Oncology
Volume16
Issue number2
DOIs
StatePublished - Jan 1 2014
Externally publishedYes

Keywords

  • glioblastoma
  • heat-shock proteins
  • immunotherapy

ASJC Scopus subject areas

  • Oncology
  • Clinical Neurology
  • Cancer Research

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    Bloch, O., Crane, C. A., Fuks, Y., Kaur, R., Aghi, M. K., Berger, M. S., Butowski, N. A., Chang, S. M., Clarke, J. L., McDermott, M. W., Prados, M. D., Sloan, A. E., Bruce, J. N., & Parsa, A. T. (2014). Heat-shock protein peptide complex-96 vaccination for recurrent glioblastoma: A phase II, single-arm trial. Neuro-Oncology, 16(2), 274-279. https://doi.org/10.1093/neuonc/not203