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Phase I study of a new cancer vaccine of ten mixed peptides for advanced cancer patients

A phase I study of a new cancer vaccine (KRM‐10), consisting of a mixture of 10 different short peptides, was conducted for patients with advanced gastrointestinal cancers. Primary or secondary endpoints included the dose‐limiting toxicity (DLT), or safety and immune responses, respectively. Peptide...

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Autores principales: Iwasa, Satoru, Yamada, Yasuhide, Heike, Yuji, Shoji, Hirokazu, Honma, Yoshitaka, Komatsu, Nobukazu, Matsueda, Satoko, Yamada, Akira, Morita, Michi, Yamaguchi, Rin, Tanaka, Natsuki, Kawahara, Akihiko, Kage, Masayoshi, Shichijo, Shigeki, Sasada, Tetsuro, Itoh, Kyogo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4970826/
https://www.ncbi.nlm.nih.gov/pubmed/26920496
http://dx.doi.org/10.1111/cas.12919
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author Iwasa, Satoru
Yamada, Yasuhide
Heike, Yuji
Shoji, Hirokazu
Honma, Yoshitaka
Komatsu, Nobukazu
Matsueda, Satoko
Yamada, Akira
Morita, Michi
Yamaguchi, Rin
Tanaka, Natsuki
Kawahara, Akihiko
Kage, Masayoshi
Shichijo, Shigeki
Sasada, Tetsuro
Itoh, Kyogo
author_facet Iwasa, Satoru
Yamada, Yasuhide
Heike, Yuji
Shoji, Hirokazu
Honma, Yoshitaka
Komatsu, Nobukazu
Matsueda, Satoko
Yamada, Akira
Morita, Michi
Yamaguchi, Rin
Tanaka, Natsuki
Kawahara, Akihiko
Kage, Masayoshi
Shichijo, Shigeki
Sasada, Tetsuro
Itoh, Kyogo
author_sort Iwasa, Satoru
collection PubMed
description A phase I study of a new cancer vaccine (KRM‐10), consisting of a mixture of 10 different short peptides, was conducted for patients with advanced gastrointestinal cancers. Primary or secondary endpoints included the dose‐limiting toxicity (DLT), or safety and immune responses, respectively. Peptide‐specific cytotoxic T lymphocytes (CTL) and immunoglobulin G (IgG), together with soluble inflammatory factors, were measured before and after vaccination. Twenty‐one patients were vaccinated with KRM‐10 at dose levels of 10 (n = 6), 20 (n = 8) or 30 mg (n = 7) of peptides every week for 6 weeks. No DLT were observed in the dose range evaluated. Common treatment‐related adverse events were a grade 1 injection site reaction in 15 patients, and fever in three patients (grade 1 in two patients and grade 2 in one patient). CTL activity to at least one peptide at the time of the third and sixth vaccination increased in 2 and 3 of 6 (10 mg), 2 of 8 and 4 of 6 (20 mg), or 2 and 1 of 6 (30 mg) patients, respectively. IgG levels, at the third and sixth vaccination, were also increased in 1 and 1 of 6 (10 mg), 2 of 8 and 4 of 6 (20 mg), or 1 and 3 of 6 (30 mg) patients, respectively. The KRM‐10 vaccine consisting of 20 mg of peptides was determined as the optimal dose for a coming phase II trial because of its safety, and also for demonstrating the most potent activity for augmenting the immune response of the three doses tested. This trial was registered at the UMIN Clinical Trials Registry as UMIN000008820.
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spelling pubmed-49708262016-09-07 Phase I study of a new cancer vaccine of ten mixed peptides for advanced cancer patients Iwasa, Satoru Yamada, Yasuhide Heike, Yuji Shoji, Hirokazu Honma, Yoshitaka Komatsu, Nobukazu Matsueda, Satoko Yamada, Akira Morita, Michi Yamaguchi, Rin Tanaka, Natsuki Kawahara, Akihiko Kage, Masayoshi Shichijo, Shigeki Sasada, Tetsuro Itoh, Kyogo Cancer Sci Original Articles A phase I study of a new cancer vaccine (KRM‐10), consisting of a mixture of 10 different short peptides, was conducted for patients with advanced gastrointestinal cancers. Primary or secondary endpoints included the dose‐limiting toxicity (DLT), or safety and immune responses, respectively. Peptide‐specific cytotoxic T lymphocytes (CTL) and immunoglobulin G (IgG), together with soluble inflammatory factors, were measured before and after vaccination. Twenty‐one patients were vaccinated with KRM‐10 at dose levels of 10 (n = 6), 20 (n = 8) or 30 mg (n = 7) of peptides every week for 6 weeks. No DLT were observed in the dose range evaluated. Common treatment‐related adverse events were a grade 1 injection site reaction in 15 patients, and fever in three patients (grade 1 in two patients and grade 2 in one patient). CTL activity to at least one peptide at the time of the third and sixth vaccination increased in 2 and 3 of 6 (10 mg), 2 of 8 and 4 of 6 (20 mg), or 2 and 1 of 6 (30 mg) patients, respectively. IgG levels, at the third and sixth vaccination, were also increased in 1 and 1 of 6 (10 mg), 2 of 8 and 4 of 6 (20 mg), or 1 and 3 of 6 (30 mg) patients, respectively. The KRM‐10 vaccine consisting of 20 mg of peptides was determined as the optimal dose for a coming phase II trial because of its safety, and also for demonstrating the most potent activity for augmenting the immune response of the three doses tested. This trial was registered at the UMIN Clinical Trials Registry as UMIN000008820. John Wiley and Sons Inc. 2016-04-26 2016-05 /pmc/articles/PMC4970826/ /pubmed/26920496 http://dx.doi.org/10.1111/cas.12919 Text en © 2016 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs (http://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Original Articles
Iwasa, Satoru
Yamada, Yasuhide
Heike, Yuji
Shoji, Hirokazu
Honma, Yoshitaka
Komatsu, Nobukazu
Matsueda, Satoko
Yamada, Akira
Morita, Michi
Yamaguchi, Rin
Tanaka, Natsuki
Kawahara, Akihiko
Kage, Masayoshi
Shichijo, Shigeki
Sasada, Tetsuro
Itoh, Kyogo
Phase I study of a new cancer vaccine of ten mixed peptides for advanced cancer patients
title Phase I study of a new cancer vaccine of ten mixed peptides for advanced cancer patients
title_full Phase I study of a new cancer vaccine of ten mixed peptides for advanced cancer patients
title_fullStr Phase I study of a new cancer vaccine of ten mixed peptides for advanced cancer patients
title_full_unstemmed Phase I study of a new cancer vaccine of ten mixed peptides for advanced cancer patients
title_short Phase I study of a new cancer vaccine of ten mixed peptides for advanced cancer patients
title_sort phase i study of a new cancer vaccine of ten mixed peptides for advanced cancer patients
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4970826/
https://www.ncbi.nlm.nih.gov/pubmed/26920496
http://dx.doi.org/10.1111/cas.12919
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