Dataset Information

A randomized, double-blind, phase III trial of personalized peptide vaccination for recurrent glioblastoma.

ABSTRACT:

Background

We conducted a phase III trial of personalized peptide vaccination (PPV) for human leukocyte antigen (HLA)-A24+ recurrent glioblastoma to develop a new treatment modality.

Methods

We randomly assigned 88 recurrent glioblastoma patients to receive PPV (n = 58) or the placebo (n = 30) at a 2-to-1 ratio. Four of 12 warehouse peptides selected based on preexisting peptide-specific immunoglobulin G levels or the corresponding placebos were injected 1×/week for 12 weeks.

Results

Our trial met neither the primary (overall survival [OS]) nor secondary endpoints. Unfavorable factors for OS of 58 PPV patients compared with 30 placebo patients were SART2-93 peptide selection (n = 13 vs 8, hazard ratio [HR]: 15.9), ?70 years old (4 vs 4, 7.87), >70 kg body weight (10 vs 7, 4.11), and performance status (PS)3 (8 vs 2, 2.82), respectively. Consequently, the median OS for PPV patients without SART2-93 selection plus one of these 3 favorable factors (<70 y old, ?70 kg, or PS0-2) was significantly longer than that for the corresponding placebo patients (HR: 0.49, 0.44, and 0.51), respectively. Preexisting immunity against both all 12 warehouse peptides besides SART2-93 and the other cytotoxic T lymphocyte epitope peptides was significantly depressed in the patients with SART2-93 selection (n = 21) compared with that of the patients without SART2-93 selection (n = 67). Biomarkers correlative for favorable OS of the PPV patients were a lower percentage of CD11b+CD14+HLA-DRlow immunosuppressive monocytes and a higher percentage of CD4+CD45RA- activated T cells, the intermediate levels of chemokine C-C ligand 2 (CCL2), vascular endothelial growth factor, interleukin (IL)-6, IL-17, or haptoglobin, respectively.

Conclusion

This phase III trial met neither the primary nor secondary endpoints.

SUBMITTER: Narita Y

PROVIDER: S-EPMC6380422 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Publications

A randomized, double-blind, phase III trial of personalized peptide vaccination for recurrent glioblastoma.

Narita Yoshitaka Y Arakawa Yoshiki Y Yamasaki Fumiyuki F Nishikawa Ryo R Aoki Tomokazu T Kanamori Masayuki M Nagane Motoo M Kumabe Toshihiro T Hirose Yuichi Y Ichikawa Tomotsugu T Kobayashi Hiroyuki H Fujimaki Takamitsu T Goto Hisaharu H Takeshima Hideo H Ueba Tetsuya T Abe Hiroshi H Tamiya Takashi T Sonoda Yukihiko Y Natsume Atsushi A Kakuma Tatsuyuki T Sugita Yasuo Y Komatsu Nobukazu N Yamada Akira A Sasada Tetsuro T Matsueda Satoko S Shichijo Shigeki S Itoh Kyogo K Terasaki Mizuhiko M

Neuro-oncology 20190201 3

<h4>Background</h4>We conducted a phase III trial of personalized peptide vaccination (PPV) for human leukocyte antigen (HLA)-A24+ recurrent glioblastoma to develop a new treatment modality.<h4>Methods</h4>We randomly assigned 88 recurrent glioblastoma patients to receive PPV (n = 58) or the placebo (n = 30) at a 2-to-1 ratio. Four of 12 warehouse peptides selected based on preexisting peptide-specific immunoglobulin G levels or the corresponding placebos were injected 1×/week for 12 weeks.<h4>R ...[more]

PMID: 30500939

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Dataset Information

A randomized, double-blind, phase III trial of personalized peptide vaccination for recurrent glioblastoma.

Background

Methods

Results

Conclusion

Publications

A randomized, double-blind, phase III trial of personalized peptide vaccination for recurrent glioblastoma.

Similar Datasets

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