Phase I Trial of Wilms' Tumor 1 (WT1) Peptide Vaccine with GM-CSF or CpG in Patients with Solid Malignancy
The aim of this study was to investigate the safety and efficacy of combinatorial use of granulocyte-macrophage colony-stimulating factor (GM-CSF) and CpG oligodeoxynucleotides (CpG-ODN) as immunoenhancement adjuvants in Wilms' Tumor 1 (WT1) vaccine therapy for patients with solid malignancy. T...
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| Veröffentlicht in: | Anticancer research 2012-06, Vol.32 (6), p.2263-2269 |
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| creator | OHNO, Satoshi OKUYAMA, Ryuji ARUGA, Atsushi SUGIYAMA, Haruo YAMAMOTO, Masakazu |
| description | The aim of this study was to investigate the safety and efficacy of combinatorial use of granulocyte-macrophage colony-stimulating factor (GM-CSF) and CpG oligodeoxynucleotides (CpG-ODN) as immunoenhancement adjuvants in Wilms' Tumor 1 (WT1) vaccine therapy for patients with solid malignancy.
The patients were placed into treatment groups as follows: WT1 peptide alone, WT1 peptide with GM-CSF (100 μg) and WT1 peptide with CpG-ODN (100 μg). HLA-A *2402 or *0201/*0206-restricted, WT1 peptide emulsified with Montanide ISA51 was injected intradermally every week for eight weeks. Toxicities were evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events ver. 3.0. Tumor size, which was measured by computed tomography, was determined every four weeks. The responses were analyzed according to Response Evaluation Criteria in Solid Tumors.
The protocol was well tolerated; only local erythema occurred at the WT1 vaccine injection site. The disease control rate of the groups treated with WT1 peptide alone (n=10), with combinatorial use of GM-CSF (n=8) and with combinatorial use of CpG-ODN (n=10), in the initial two months was 20%, 25% and 60%, respectively.
Addition of GM-CSF or CpG-ODN to the WT1 peptide vaccine for patients with solid malignancy was safe and improved the effectiveness of clinical response. |
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The patients were placed into treatment groups as follows: WT1 peptide alone, WT1 peptide with GM-CSF (100 μg) and WT1 peptide with CpG-ODN (100 μg). HLA-A *2402 or *0201/*0206-restricted, WT1 peptide emulsified with Montanide ISA51 was injected intradermally every week for eight weeks. Toxicities were evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events ver. 3.0. Tumor size, which was measured by computed tomography, was determined every four weeks. The responses were analyzed according to Response Evaluation Criteria in Solid Tumors.
The protocol was well tolerated; only local erythema occurred at the WT1 vaccine injection site. The disease control rate of the groups treated with WT1 peptide alone (n=10), with combinatorial use of GM-CSF (n=8) and with combinatorial use of CpG-ODN (n=10), in the initial two months was 20%, 25% and 60%, respectively.
Addition of GM-CSF or CpG-ODN to the WT1 peptide vaccine for patients with solid malignancy was safe and improved the effectiveness of clinical response.</description><identifier>ISSN: 0250-7005</identifier><identifier>EISSN: 1791-7530</identifier><identifier>PMID: 22641661</identifier><language>eng</language><publisher>Attiki: International Institute of Anticancer Research</publisher><subject><![CDATA[Adjuvants ; Adjuvants, Immunologic - administration & dosage ; Adjuvants, Immunologic - adverse effects ; Aged ; Biological and medical sciences ; Cancer Vaccines - administration & dosage ; Cancer Vaccines - adverse effects ; Cancer Vaccines - immunology ; Clinical trials ; Computed tomography ; CpG islands ; CpG Islands - immunology ; Disease control ; Erythema ; Female ; Granulocyte-macrophage colony-stimulating factor ; Granulocyte-Macrophage Colony-Stimulating Factor - administration & dosage ; Granulocyte-Macrophage Colony-Stimulating Factor - adverse effects ; Granulocyte-Macrophage Colony-Stimulating Factor - immunology ; Histocompatibility antigen HLA ; Humans ; Immunohistochemistry ; Kidneys ; Male ; Malignancy ; Mannitol - administration & dosage ; Mannitol - adverse effects ; Mannitol - analogs & derivatives ; Mannitol - immunology ; Medical sciences ; Middle Aged ; Neoplasms - immunology ; Neoplasms - therapy ; Nephrology. Urinary tract diseases ; Oleic Acids - administration & dosage ; Oleic Acids - adverse effects ; Oleic Acids - immunology ; Oligonucleotides ; Oligonucleotides - administration & dosage ; Oligonucleotides - adverse effects ; Oligonucleotides - immunology ; Solid tumors ; Toxicity ; Tumors ; Tumors of the urinary system ; Vaccines ; Vaccines, Subunit - administration & dosage ; Vaccines, Subunit - adverse effects ; Vaccines, Subunit - immunology ; WT1 protein ; WT1 Proteins - administration & dosage ; WT1 Proteins - adverse effects ; WT1 Proteins - immunology]]></subject><ispartof>Anticancer research, 2012-06, Vol.32 (6), p.2263-2269</ispartof><rights>2015 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>309,310,314,776,780,785,786,23910,23911,25119</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=26113465$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22641661$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>OHNO, Satoshi</creatorcontrib><creatorcontrib>OKUYAMA, Ryuji</creatorcontrib><creatorcontrib>ARUGA, Atsushi</creatorcontrib><creatorcontrib>SUGIYAMA, Haruo</creatorcontrib><creatorcontrib>YAMAMOTO, Masakazu</creatorcontrib><title>Phase I Trial of Wilms' Tumor 1 (WT1) Peptide Vaccine with GM-CSF or CpG in Patients with Solid Malignancy</title><title>Anticancer research</title><addtitle>Anticancer Res</addtitle><description>The aim of this study was to investigate the safety and efficacy of combinatorial use of granulocyte-macrophage colony-stimulating factor (GM-CSF) and CpG oligodeoxynucleotides (CpG-ODN) as immunoenhancement adjuvants in Wilms' Tumor 1 (WT1) vaccine therapy for patients with solid malignancy.
The patients were placed into treatment groups as follows: WT1 peptide alone, WT1 peptide with GM-CSF (100 μg) and WT1 peptide with CpG-ODN (100 μg). HLA-A *2402 or *0201/*0206-restricted, WT1 peptide emulsified with Montanide ISA51 was injected intradermally every week for eight weeks. Toxicities were evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events ver. 3.0. Tumor size, which was measured by computed tomography, was determined every four weeks. The responses were analyzed according to Response Evaluation Criteria in Solid Tumors.
The protocol was well tolerated; only local erythema occurred at the WT1 vaccine injection site. The disease control rate of the groups treated with WT1 peptide alone (n=10), with combinatorial use of GM-CSF (n=8) and with combinatorial use of CpG-ODN (n=10), in the initial two months was 20%, 25% and 60%, respectively.
Addition of GM-CSF or CpG-ODN to the WT1 peptide vaccine for patients with solid malignancy was safe and improved the effectiveness of clinical response.</description><subject>Adjuvants</subject><subject>Adjuvants, Immunologic - administration & dosage</subject><subject>Adjuvants, Immunologic - adverse effects</subject><subject>Aged</subject><subject>Biological and medical sciences</subject><subject>Cancer Vaccines - administration & dosage</subject><subject>Cancer Vaccines - adverse effects</subject><subject>Cancer Vaccines - immunology</subject><subject>Clinical trials</subject><subject>Computed tomography</subject><subject>CpG islands</subject><subject>CpG Islands - immunology</subject><subject>Disease control</subject><subject>Erythema</subject><subject>Female</subject><subject>Granulocyte-macrophage colony-stimulating factor</subject><subject>Granulocyte-Macrophage Colony-Stimulating Factor - administration & dosage</subject><subject>Granulocyte-Macrophage Colony-Stimulating Factor - adverse effects</subject><subject>Granulocyte-Macrophage Colony-Stimulating Factor - immunology</subject><subject>Histocompatibility antigen HLA</subject><subject>Humans</subject><subject>Immunohistochemistry</subject><subject>Kidneys</subject><subject>Male</subject><subject>Malignancy</subject><subject>Mannitol - administration & dosage</subject><subject>Mannitol - adverse effects</subject><subject>Mannitol - analogs & derivatives</subject><subject>Mannitol - immunology</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Neoplasms - immunology</subject><subject>Neoplasms - therapy</subject><subject>Nephrology. Urinary tract diseases</subject><subject>Oleic Acids - administration & dosage</subject><subject>Oleic Acids - adverse effects</subject><subject>Oleic Acids - immunology</subject><subject>Oligonucleotides</subject><subject>Oligonucleotides - administration & dosage</subject><subject>Oligonucleotides - adverse effects</subject><subject>Oligonucleotides - immunology</subject><subject>Solid tumors</subject><subject>Toxicity</subject><subject>Tumors</subject><subject>Tumors of the urinary system</subject><subject>Vaccines</subject><subject>Vaccines, Subunit - administration & dosage</subject><subject>Vaccines, Subunit - adverse effects</subject><subject>Vaccines, Subunit - immunology</subject><subject>WT1 protein</subject><subject>WT1 Proteins - administration & dosage</subject><subject>WT1 Proteins - adverse effects</subject><subject>WT1 Proteins - immunology</subject><issn>0250-7005</issn><issn>1791-7530</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpF0F1LwzAUBuAgipvTvyDnRpwXhXy0SXspxc3BhoNVd1nSNHEZ6YdNi-zfW3Di1YHzPhx4zwWaEpGQQEQMX6IpphEOBMbRBN14f8SY8yRm12hCKQ8J52SKjtuD9BpWkHVWOmgM7K2r_CNkQ9V0QGC-z8gTbHXb21LDh1TK1hq-bX-A5SZIdwsYWdouwdawlb3Vde9_413jbAkb6exnLWt1ukVXRjqv785zht4XL1n6Gqzflqv0eR20VIR9wBOhMKOs1KpgLKaRMqUKsSlDXvACM6ZjqZkxhGJOjCmExhFXiYpUGY57xWZo_nu37ZqvQfs-r6xX2jlZ62bwOcE0xpRTwUZ6f6ZDUekybztbye6U__1nBA9nIL2SznRjEev_HSeEhTxiP2s-bPI</recordid><startdate>20120601</startdate><enddate>20120601</enddate><creator>OHNO, Satoshi</creator><creator>OKUYAMA, Ryuji</creator><creator>ARUGA, Atsushi</creator><creator>SUGIYAMA, Haruo</creator><creator>YAMAMOTO, Masakazu</creator><general>International Institute of Anticancer Research</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7T5</scope><scope>H94</scope></search><sort><creationdate>20120601</creationdate><title>Phase I Trial of Wilms' Tumor 1 (WT1) Peptide Vaccine with GM-CSF or CpG in Patients with Solid Malignancy</title><author>OHNO, Satoshi ; OKUYAMA, Ryuji ; ARUGA, Atsushi ; SUGIYAMA, Haruo ; YAMAMOTO, Masakazu</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p274t-697c0323decb33825cfdc40fd46b6b033e8ae3ff12061ffb7e056c9c5cd4e3fc3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Adjuvants</topic><topic>Adjuvants, Immunologic - administration & dosage</topic><topic>Adjuvants, Immunologic - adverse effects</topic><topic>Aged</topic><topic>Biological and medical sciences</topic><topic>Cancer Vaccines - administration & dosage</topic><topic>Cancer Vaccines - adverse effects</topic><topic>Cancer Vaccines - immunology</topic><topic>Clinical trials</topic><topic>Computed tomography</topic><topic>CpG islands</topic><topic>CpG Islands - immunology</topic><topic>Disease control</topic><topic>Erythema</topic><topic>Female</topic><topic>Granulocyte-macrophage colony-stimulating factor</topic><topic>Granulocyte-Macrophage Colony-Stimulating Factor - administration & dosage</topic><topic>Granulocyte-Macrophage Colony-Stimulating Factor - adverse effects</topic><topic>Granulocyte-Macrophage Colony-Stimulating Factor - immunology</topic><topic>Histocompatibility antigen HLA</topic><topic>Humans</topic><topic>Immunohistochemistry</topic><topic>Kidneys</topic><topic>Male</topic><topic>Malignancy</topic><topic>Mannitol - administration & dosage</topic><topic>Mannitol - adverse effects</topic><topic>Mannitol - analogs & derivatives</topic><topic>Mannitol - immunology</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Neoplasms - immunology</topic><topic>Neoplasms - therapy</topic><topic>Nephrology. Urinary tract diseases</topic><topic>Oleic Acids - administration & dosage</topic><topic>Oleic Acids - adverse effects</topic><topic>Oleic Acids - immunology</topic><topic>Oligonucleotides</topic><topic>Oligonucleotides - administration & dosage</topic><topic>Oligonucleotides - adverse effects</topic><topic>Oligonucleotides - immunology</topic><topic>Solid tumors</topic><topic>Toxicity</topic><topic>Tumors</topic><topic>Tumors of the urinary system</topic><topic>Vaccines</topic><topic>Vaccines, Subunit - administration & dosage</topic><topic>Vaccines, Subunit - adverse effects</topic><topic>Vaccines, Subunit - immunology</topic><topic>WT1 protein</topic><topic>WT1 Proteins - administration & dosage</topic><topic>WT1 Proteins - adverse effects</topic><topic>WT1 Proteins - immunology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>OHNO, Satoshi</creatorcontrib><creatorcontrib>OKUYAMA, Ryuji</creatorcontrib><creatorcontrib>ARUGA, Atsushi</creatorcontrib><creatorcontrib>SUGIYAMA, Haruo</creatorcontrib><creatorcontrib>YAMAMOTO, Masakazu</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><jtitle>Anticancer research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>OHNO, Satoshi</au><au>OKUYAMA, Ryuji</au><au>ARUGA, Atsushi</au><au>SUGIYAMA, Haruo</au><au>YAMAMOTO, Masakazu</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase I Trial of Wilms' Tumor 1 (WT1) Peptide Vaccine with GM-CSF or CpG in Patients with Solid Malignancy</atitle><jtitle>Anticancer research</jtitle><addtitle>Anticancer Res</addtitle><date>2012-06-01</date><risdate>2012</risdate><volume>32</volume><issue>6</issue><spage>2263</spage><epage>2269</epage><pages>2263-2269</pages><issn>0250-7005</issn><eissn>1791-7530</eissn><abstract>The aim of this study was to investigate the safety and efficacy of combinatorial use of granulocyte-macrophage colony-stimulating factor (GM-CSF) and CpG oligodeoxynucleotides (CpG-ODN) as immunoenhancement adjuvants in Wilms' Tumor 1 (WT1) vaccine therapy for patients with solid malignancy.
The patients were placed into treatment groups as follows: WT1 peptide alone, WT1 peptide with GM-CSF (100 μg) and WT1 peptide with CpG-ODN (100 μg). HLA-A *2402 or *0201/*0206-restricted, WT1 peptide emulsified with Montanide ISA51 was injected intradermally every week for eight weeks. Toxicities were evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events ver. 3.0. Tumor size, which was measured by computed tomography, was determined every four weeks. The responses were analyzed according to Response Evaluation Criteria in Solid Tumors.
The protocol was well tolerated; only local erythema occurred at the WT1 vaccine injection site. The disease control rate of the groups treated with WT1 peptide alone (n=10), with combinatorial use of GM-CSF (n=8) and with combinatorial use of CpG-ODN (n=10), in the initial two months was 20%, 25% and 60%, respectively.
Addition of GM-CSF or CpG-ODN to the WT1 peptide vaccine for patients with solid malignancy was safe and improved the effectiveness of clinical response.</abstract><cop>Attiki</cop><pub>International Institute of Anticancer Research</pub><pmid>22641661</pmid><tpages>7</tpages></addata></record> |
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| ispartof | Anticancer research, 2012-06, Vol.32 (6), p.2263-2269 |
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| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals |
| subjects | Adjuvants Adjuvants, Immunologic - administration & dosage Adjuvants, Immunologic - adverse effects Aged Biological and medical sciences Cancer Vaccines - administration & dosage Cancer Vaccines - adverse effects Cancer Vaccines - immunology Clinical trials Computed tomography CpG islands CpG Islands - immunology Disease control Erythema Female Granulocyte-macrophage colony-stimulating factor Granulocyte-Macrophage Colony-Stimulating Factor - administration & dosage Granulocyte-Macrophage Colony-Stimulating Factor - adverse effects Granulocyte-Macrophage Colony-Stimulating Factor - immunology Histocompatibility antigen HLA Humans Immunohistochemistry Kidneys Male Malignancy Mannitol - administration & dosage Mannitol - adverse effects Mannitol - analogs & derivatives Mannitol - immunology Medical sciences Middle Aged Neoplasms - immunology Neoplasms - therapy Nephrology. Urinary tract diseases Oleic Acids - administration & dosage Oleic Acids - adverse effects Oleic Acids - immunology Oligonucleotides Oligonucleotides - administration & dosage Oligonucleotides - adverse effects Oligonucleotides - immunology Solid tumors Toxicity Tumors Tumors of the urinary system Vaccines Vaccines, Subunit - administration & dosage Vaccines, Subunit - adverse effects Vaccines, Subunit - immunology WT1 protein WT1 Proteins - administration & dosage WT1 Proteins - adverse effects WT1 Proteins - immunology |
| title | Phase I Trial of Wilms' Tumor 1 (WT1) Peptide Vaccine with GM-CSF or CpG in Patients with Solid Malignancy |
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