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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...
Autores principales: | , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2016
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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. |
format | Online Article Text |
id | pubmed-4970826 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
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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