Efficacy of the NCCV Cocktail-1 vaccine for refractory pediatric solid tumors: A phase I clinical trial

Yu Akazawa, Ako Hosono, Toshiaki Yoshikawa, Hide Kaneda, Chika Nitani, Junichi Hara, Yoshiaki Kinoshita, Kenichi Kohashi, Atsushi Manabe, Miki Fukutani, Masashi Wakabayashi, Akihiro Sato, Kayoko Shoda, Manami Shimomura, Shoichi Mizuno, Yasunari Nakamoto, Tetsuya Nakatsura

研究成果: ジャーナルへの寄稿記事

抄録

Pediatric refractory solid tumors are aggressive malignant diseases, resulting in an extremely poor prognosis. KOC1, FOXM1, and KIF20A are cancer antigens that could be ideal targets for anticancer immunotherapy against pediatric refractory solid tumors with positive expression for these antigens. This nonrandomized, open-label, phase I clinical trial evaluated the safety and efficacy of the NCCV Cocktail-1 vaccine, which is a cocktail of cancer peptides derived from KOC1, FOXM1, and KIF20A, in patients with pediatric refractory solid tumors. Twelve patients with refractory pediatric solid tumors underwent NCCV Cocktail-1 vaccination weekly by intradermal injections. The primary endpoint was the safety of the NCCV Cocktail-1 vaccination, and the secondary endpoints were the immune response, as measured by interferon-r enzyme-linked immunospot assay, and the clinical outcomes including tumor response and progression-free survival. The NCCV Cocktail-1 vaccine was well tolerated. The clinical response of this trial showed that 4 patients had stable disease after 8 weeks and 2 patients maintained remission for >11 months. In 4, 8, and 5 patients, the NCCV Cocktail-1 vaccine induced the sufficient number of peptide-specific CTLs for KOC1, FOXM1, and KIF20A, respectively. Patients with high peptide-specific CTL frequencies for KOC1, FOXM1, and KIF20A had better progression-free survival than those with low frequencies. The findings of this clinical trial showed that the NCCV Cocktail-1 vaccine could be a novel therapeutic strategy, with adequate effects against pediatric refractory solid tumors. Future large-scale trials should evaluate the efficacy of the NCCV Cocktail-1 vaccination.

元の言語英語
ページ(範囲)3650-3662
ページ数13
ジャーナルCancer Science
110
発行部数12
DOI
出版物ステータス出版済み - 12 1 2019

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Clinical Trials, Phase I
Vaccines
Pediatrics
Neoplasms
Vaccination
Peptides
Disease-Free Survival
Clinical Trials
Safety
Enzyme-Linked Immunospot Assay
Antigens
Intradermal Injections
Immunotherapy
Interferons

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

これを引用

Akazawa, Y., Hosono, A., Yoshikawa, T., Kaneda, H., Nitani, C., Hara, J., ... Nakatsura, T. (2019). Efficacy of the NCCV Cocktail-1 vaccine for refractory pediatric solid tumors: A phase I clinical trial. Cancer Science, 110(12), 3650-3662. https://doi.org/10.1111/cas.14206

Efficacy of the NCCV Cocktail-1 vaccine for refractory pediatric solid tumors : A phase I clinical trial. / Akazawa, Yu; Hosono, Ako; Yoshikawa, Toshiaki; Kaneda, Hide; Nitani, Chika; Hara, Junichi; Kinoshita, Yoshiaki; Kohashi, Kenichi; Manabe, Atsushi; Fukutani, Miki; Wakabayashi, Masashi; Sato, Akihiro; Shoda, Kayoko; Shimomura, Manami; Mizuno, Shoichi; Nakamoto, Yasunari; Nakatsura, Tetsuya.

:: Cancer Science, 巻 110, 番号 12, 01.12.2019, p. 3650-3662.

研究成果: ジャーナルへの寄稿記事

Akazawa, Y, Hosono, A, Yoshikawa, T, Kaneda, H, Nitani, C, Hara, J, Kinoshita, Y, Kohashi, K, Manabe, A, Fukutani, M, Wakabayashi, M, Sato, A, Shoda, K, Shimomura, M, Mizuno, S, Nakamoto, Y & Nakatsura, T 2019, 'Efficacy of the NCCV Cocktail-1 vaccine for refractory pediatric solid tumors: A phase I clinical trial', Cancer Science, 巻. 110, 番号 12, pp. 3650-3662. https://doi.org/10.1111/cas.14206
Akazawa Y, Hosono A, Yoshikawa T, Kaneda H, Nitani C, Hara J その他. Efficacy of the NCCV Cocktail-1 vaccine for refractory pediatric solid tumors: A phase I clinical trial. Cancer Science. 2019 12 1;110(12):3650-3662. https://doi.org/10.1111/cas.14206
Akazawa, Yu ; Hosono, Ako ; Yoshikawa, Toshiaki ; Kaneda, Hide ; Nitani, Chika ; Hara, Junichi ; Kinoshita, Yoshiaki ; Kohashi, Kenichi ; Manabe, Atsushi ; Fukutani, Miki ; Wakabayashi, Masashi ; Sato, Akihiro ; Shoda, Kayoko ; Shimomura, Manami ; Mizuno, Shoichi ; Nakamoto, Yasunari ; Nakatsura, Tetsuya. / Efficacy of the NCCV Cocktail-1 vaccine for refractory pediatric solid tumors : A phase I clinical trial. :: Cancer Science. 2019 ; 巻 110, 番号 12. pp. 3650-3662.
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abstract = "Pediatric refractory solid tumors are aggressive malignant diseases, resulting in an extremely poor prognosis. KOC1, FOXM1, and KIF20A are cancer antigens that could be ideal targets for anticancer immunotherapy against pediatric refractory solid tumors with positive expression for these antigens. This nonrandomized, open-label, phase I clinical trial evaluated the safety and efficacy of the NCCV Cocktail-1 vaccine, which is a cocktail of cancer peptides derived from KOC1, FOXM1, and KIF20A, in patients with pediatric refractory solid tumors. Twelve patients with refractory pediatric solid tumors underwent NCCV Cocktail-1 vaccination weekly by intradermal injections. The primary endpoint was the safety of the NCCV Cocktail-1 vaccination, and the secondary endpoints were the immune response, as measured by interferon-r enzyme-linked immunospot assay, and the clinical outcomes including tumor response and progression-free survival. The NCCV Cocktail-1 vaccine was well tolerated. The clinical response of this trial showed that 4 patients had stable disease after 8 weeks and 2 patients maintained remission for >11 months. In 4, 8, and 5 patients, the NCCV Cocktail-1 vaccine induced the sufficient number of peptide-specific CTLs for KOC1, FOXM1, and KIF20A, respectively. Patients with high peptide-specific CTL frequencies for KOC1, FOXM1, and KIF20A had better progression-free survival than those with low frequencies. The findings of this clinical trial showed that the NCCV Cocktail-1 vaccine could be a novel therapeutic strategy, with adequate effects against pediatric refractory solid tumors. Future large-scale trials should evaluate the efficacy of the NCCV Cocktail-1 vaccination.",
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AU - Akazawa, Yu

AU - Hosono, Ako

AU - Yoshikawa, Toshiaki

AU - Kaneda, Hide

AU - Nitani, Chika

AU - Hara, Junichi

AU - Kinoshita, Yoshiaki

AU - Kohashi, Kenichi

AU - Manabe, Atsushi

AU - Fukutani, Miki

AU - Wakabayashi, Masashi

AU - Sato, Akihiro

AU - Shoda, Kayoko

AU - Shimomura, Manami

AU - Mizuno, Shoichi

AU - Nakamoto, Yasunari

AU - Nakatsura, Tetsuya

PY - 2019/12/1

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