Phase I trial of p28 (NSC745104), a non-HDM2-mediated peptide inhibitor of p53 ubiquitination in pediatric patients with recurrent or progressive central nervous system tumors: A Pediatric Brain Tumor Consortium Study
p53 is a promising target in human cancer. p28 is a cell-penetrating peptide that preferentially enters cancer cells and binds to both wild-type and mutant p53 protein, inhibiting COP1-mediated ubiquitination and proteasomal degradation. This results in increased levels of p53, which induces cell cy...
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creator | Lulla, Rishi R Goldman, Stewart Yamada, Tohru Beattie, Craig W Bressler, Linda Pacini, Michael Pollack, Ian F Fisher, Paul Graham Packer, Roger J Dunkel, Ira J Dhall, Girish Wu, Shengjie Onar, Arzu Boyett, James M Fouladi, Maryam |
description | p53 is a promising target in human cancer. p28 is a cell-penetrating peptide that preferentially enters cancer cells and binds to both wild-type and mutant p53 protein, inhibiting COP1-mediated ubiquitination and proteasomal degradation. This results in increased levels of p53, which induces cell cycle arrest at G2/M. We conducted a phase I study to determine the maximum-tolerated dose (MTD) and describe the dose-limiting toxicities (DLTs) and pharmacokinetics (PKs) of p28 in children.
Children aged 3-21 years with recurrent or progressive central nervous system tumors were eligible. Intravenous p28 was administered 3 times weekly for 4 consecutive weeks of a 6-week cycle at 4.16 mg/kg/dose (the adult recommended phase II dose) using a rolling-6 study design. Expression status of p53 was characterized by immunohistochemistry, and serum PK parameters were established on the second dose.
Of the 18 eligible patients enrolled in the study, 12 completed the DLT monitoring period and were evaluable for toxicity. p28 was well-tolerated; 7 participants received ≥2 courses, and the most common adverse event attributed to the drug was transient grade 1 infusion-related reaction. PK analysis revealed a profile similar to adults; however, an increased area under the curve was observed in pediatric patients. High p53 expression in tumor cell nuclei was observed in 6 of 12 available tissue samples. There were no objective responses; 2 participants remained stable on the study for >4 cycles.
This phase I study demonstrated that p28 is well-tolerated in children with recurrent CNS malignancies at the adult recommended phase II dose. |
doi_str_mv | 10.1093/neuonc/now047 |
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Children aged 3-21 years with recurrent or progressive central nervous system tumors were eligible. Intravenous p28 was administered 3 times weekly for 4 consecutive weeks of a 6-week cycle at 4.16 mg/kg/dose (the adult recommended phase II dose) using a rolling-6 study design. Expression status of p53 was characterized by immunohistochemistry, and serum PK parameters were established on the second dose.
Of the 18 eligible patients enrolled in the study, 12 completed the DLT monitoring period and were evaluable for toxicity. p28 was well-tolerated; 7 participants received ≥2 courses, and the most common adverse event attributed to the drug was transient grade 1 infusion-related reaction. PK analysis revealed a profile similar to adults; however, an increased area under the curve was observed in pediatric patients. High p53 expression in tumor cell nuclei was observed in 6 of 12 available tissue samples. There were no objective responses; 2 participants remained stable on the study for >4 cycles.
This phase I study demonstrated that p28 is well-tolerated in children with recurrent CNS malignancies at the adult recommended phase II dose.</description><identifier>ISSN: 1522-8517</identifier><identifier>EISSN: 1523-5866</identifier><identifier>DOI: 10.1093/neuonc/now047</identifier><identifier>PMID: 27022131</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Adolescent ; Adult ; Antineoplastic Agents - pharmacokinetics ; Antineoplastic Agents - therapeutic use ; Azurin - pharmacokinetics ; Azurin - therapeutic use ; Central Nervous System Neoplasms - drug therapy ; Central Nervous System Neoplasms - metabolism ; Central Nervous System Neoplasms - pathology ; Child ; Child, Preschool ; Clinical Investigation ; Dose-Response Relationship, Drug ; Female ; Follow-Up Studies ; Humans ; Male ; Maximum Tolerated Dose ; Neoplasm Recurrence, Local - drug therapy ; Neoplasm Recurrence, Local - metabolism ; Neoplasm Recurrence, Local - pathology ; Neoplasm Staging ; Peptide Fragments - pharmacokinetics ; Peptide Fragments - therapeutic use ; Prognosis ; Tumor Suppressor Protein p53 - metabolism ; Ubiquitination - drug effects ; Young Adult</subject><ispartof>Neuro-oncology (Charlottesville, Va.), 2016-09, Vol.18 (9), p.1319-1325</ispartof><rights>The Author(s) 2016. Published by Oxford University Press on behalf of the Society for Neuro-Oncology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.</rights><rights>The Author(s) 2016. Published by Oxford University Press on behalf of the Society for Neuro-Oncology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com. 2016</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3357-826c951b1eebcdc28a0c1a4b553e74afc0f710c490f928b2fa2b2bb3032e3fdf3</citedby><cites>FETCH-LOGICAL-c3357-826c951b1eebcdc28a0c1a4b553e74afc0f710c490f928b2fa2b2bb3032e3fdf3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4999001/pdf/$$EPDF$$P50$$Gpubmedcentral$$H</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4999001/$$EHTML$$P50$$Gpubmedcentral$$H</linktohtml><link.rule.ids>230,314,723,776,780,881,27903,27904,53769,53771</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27022131$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lulla, Rishi R</creatorcontrib><creatorcontrib>Goldman, Stewart</creatorcontrib><creatorcontrib>Yamada, Tohru</creatorcontrib><creatorcontrib>Beattie, Craig W</creatorcontrib><creatorcontrib>Bressler, Linda</creatorcontrib><creatorcontrib>Pacini, Michael</creatorcontrib><creatorcontrib>Pollack, Ian F</creatorcontrib><creatorcontrib>Fisher, Paul Graham</creatorcontrib><creatorcontrib>Packer, Roger J</creatorcontrib><creatorcontrib>Dunkel, Ira J</creatorcontrib><creatorcontrib>Dhall, Girish</creatorcontrib><creatorcontrib>Wu, Shengjie</creatorcontrib><creatorcontrib>Onar, Arzu</creatorcontrib><creatorcontrib>Boyett, James M</creatorcontrib><creatorcontrib>Fouladi, Maryam</creatorcontrib><title>Phase I trial of p28 (NSC745104), a non-HDM2-mediated peptide inhibitor of p53 ubiquitination in pediatric patients with recurrent or progressive central nervous system tumors: A Pediatric Brain Tumor Consortium Study</title><title>Neuro-oncology (Charlottesville, Va.)</title><addtitle>Neuro Oncol</addtitle><description>p53 is a promising target in human cancer. p28 is a cell-penetrating peptide that preferentially enters cancer cells and binds to both wild-type and mutant p53 protein, inhibiting COP1-mediated ubiquitination and proteasomal degradation. This results in increased levels of p53, which induces cell cycle arrest at G2/M. We conducted a phase I study to determine the maximum-tolerated dose (MTD) and describe the dose-limiting toxicities (DLTs) and pharmacokinetics (PKs) of p28 in children.
Children aged 3-21 years with recurrent or progressive central nervous system tumors were eligible. Intravenous p28 was administered 3 times weekly for 4 consecutive weeks of a 6-week cycle at 4.16 mg/kg/dose (the adult recommended phase II dose) using a rolling-6 study design. Expression status of p53 was characterized by immunohistochemistry, and serum PK parameters were established on the second dose.
Of the 18 eligible patients enrolled in the study, 12 completed the DLT monitoring period and were evaluable for toxicity. p28 was well-tolerated; 7 participants received ≥2 courses, and the most common adverse event attributed to the drug was transient grade 1 infusion-related reaction. PK analysis revealed a profile similar to adults; however, an increased area under the curve was observed in pediatric patients. High p53 expression in tumor cell nuclei was observed in 6 of 12 available tissue samples. There were no objective responses; 2 participants remained stable on the study for >4 cycles.
This phase I study demonstrated that p28 is well-tolerated in children with recurrent CNS malignancies at the adult recommended phase II dose.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Antineoplastic Agents - pharmacokinetics</subject><subject>Antineoplastic Agents - therapeutic use</subject><subject>Azurin - pharmacokinetics</subject><subject>Azurin - therapeutic use</subject><subject>Central Nervous System Neoplasms - drug therapy</subject><subject>Central Nervous System Neoplasms - metabolism</subject><subject>Central Nervous System Neoplasms - pathology</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Clinical Investigation</subject><subject>Dose-Response Relationship, Drug</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Male</subject><subject>Maximum Tolerated Dose</subject><subject>Neoplasm Recurrence, Local - drug therapy</subject><subject>Neoplasm Recurrence, Local - metabolism</subject><subject>Neoplasm Recurrence, Local - pathology</subject><subject>Neoplasm Staging</subject><subject>Peptide Fragments - pharmacokinetics</subject><subject>Peptide Fragments - therapeutic use</subject><subject>Prognosis</subject><subject>Tumor Suppressor Protein p53 - metabolism</subject><subject>Ubiquitination - drug effects</subject><subject>Young Adult</subject><issn>1522-8517</issn><issn>1523-5866</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpVUk1v1DAUjBCIlsKRK3rHIhHqj3iTcKhUtkArFajUco5s56VrtLFTf2y1P7X_Bm93WcHJ9pt588b2FMVbSj5S0vITi8lZfWLdA6nqZ8UhFYyXopnNnj_tWdkIWh8Ur0L4TQijYkZfFgesJoxRTg-Lx-uFDAiXEL2RS3ADTKyB4x8387oSlFTvP4AE62x5cf6dlSP2RkbsYcIpmh7B2IVRJjr_1Ck4JGXuk4nGymiczXimbnq80TDlGtoY4MHEBXjUyft8htw9eXfnMQSzQtC55rMXi37lUoCwDhFHiGl0PnyCM7jeK372Mk-43SAwdzY4H00a4Samfv26eDHIZcA3u_Wo-PX1y-38orz6-e1yfnZVas5FXTZspltBFUVUuteskURTWSkhONaVHDQZakp01ZKhZY1ig2SKKcUJZ8iHfuBHxelWd0oqv8_OfTd5M0q_7pw03f-INYvuzq26qm1bQmgWON4JeHefMMRuNEHjcikt5vt3tKEt5XUz21DLLVV7F4LHYT-Gkm4Th24bh24bh8x_96-3Pfvv__M_wIS37Q</recordid><startdate>20160901</startdate><enddate>20160901</enddate><creator>Lulla, Rishi R</creator><creator>Goldman, Stewart</creator><creator>Yamada, Tohru</creator><creator>Beattie, Craig W</creator><creator>Bressler, Linda</creator><creator>Pacini, Michael</creator><creator>Pollack, Ian F</creator><creator>Fisher, Paul Graham</creator><creator>Packer, Roger J</creator><creator>Dunkel, Ira J</creator><creator>Dhall, Girish</creator><creator>Wu, Shengjie</creator><creator>Onar, Arzu</creator><creator>Boyett, James M</creator><creator>Fouladi, Maryam</creator><general>Oxford University Press</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7TK</scope><scope>5PM</scope></search><sort><creationdate>20160901</creationdate><title>Phase I trial of p28 (NSC745104), a non-HDM2-mediated peptide inhibitor of p53 ubiquitination in pediatric patients with recurrent or progressive central nervous system tumors: A Pediatric Brain Tumor Consortium Study</title><author>Lulla, Rishi R ; Goldman, Stewart ; Yamada, Tohru ; Beattie, Craig W ; Bressler, Linda ; Pacini, Michael ; Pollack, Ian F ; Fisher, Paul Graham ; Packer, Roger J ; Dunkel, Ira J ; Dhall, Girish ; Wu, Shengjie ; Onar, Arzu ; Boyett, James M ; Fouladi, Maryam</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3357-826c951b1eebcdc28a0c1a4b553e74afc0f710c490f928b2fa2b2bb3032e3fdf3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Antineoplastic Agents - pharmacokinetics</topic><topic>Antineoplastic Agents - therapeutic use</topic><topic>Azurin - pharmacokinetics</topic><topic>Azurin - therapeutic use</topic><topic>Central Nervous System Neoplasms - drug therapy</topic><topic>Central Nervous System Neoplasms - metabolism</topic><topic>Central Nervous System Neoplasms - pathology</topic><topic>Child</topic><topic>Child, Preschool</topic><topic>Clinical Investigation</topic><topic>Dose-Response Relationship, Drug</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Humans</topic><topic>Male</topic><topic>Maximum Tolerated Dose</topic><topic>Neoplasm Recurrence, Local - drug therapy</topic><topic>Neoplasm Recurrence, Local - metabolism</topic><topic>Neoplasm Recurrence, Local - pathology</topic><topic>Neoplasm Staging</topic><topic>Peptide Fragments - pharmacokinetics</topic><topic>Peptide Fragments - therapeutic use</topic><topic>Prognosis</topic><topic>Tumor Suppressor Protein p53 - metabolism</topic><topic>Ubiquitination - drug effects</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lulla, Rishi R</creatorcontrib><creatorcontrib>Goldman, Stewart</creatorcontrib><creatorcontrib>Yamada, Tohru</creatorcontrib><creatorcontrib>Beattie, Craig W</creatorcontrib><creatorcontrib>Bressler, Linda</creatorcontrib><creatorcontrib>Pacini, Michael</creatorcontrib><creatorcontrib>Pollack, Ian F</creatorcontrib><creatorcontrib>Fisher, Paul Graham</creatorcontrib><creatorcontrib>Packer, Roger J</creatorcontrib><creatorcontrib>Dunkel, Ira J</creatorcontrib><creatorcontrib>Dhall, Girish</creatorcontrib><creatorcontrib>Wu, Shengjie</creatorcontrib><creatorcontrib>Onar, Arzu</creatorcontrib><creatorcontrib>Boyett, James M</creatorcontrib><creatorcontrib>Fouladi, Maryam</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Neurosciences Abstracts</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Neuro-oncology (Charlottesville, Va.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lulla, Rishi R</au><au>Goldman, Stewart</au><au>Yamada, Tohru</au><au>Beattie, Craig W</au><au>Bressler, Linda</au><au>Pacini, Michael</au><au>Pollack, Ian F</au><au>Fisher, Paul Graham</au><au>Packer, Roger J</au><au>Dunkel, Ira J</au><au>Dhall, Girish</au><au>Wu, Shengjie</au><au>Onar, Arzu</au><au>Boyett, James M</au><au>Fouladi, Maryam</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase I trial of p28 (NSC745104), a non-HDM2-mediated peptide inhibitor of p53 ubiquitination in pediatric patients with recurrent or progressive central nervous system tumors: A Pediatric Brain Tumor Consortium Study</atitle><jtitle>Neuro-oncology (Charlottesville, Va.)</jtitle><addtitle>Neuro Oncol</addtitle><date>2016-09-01</date><risdate>2016</risdate><volume>18</volume><issue>9</issue><spage>1319</spage><epage>1325</epage><pages>1319-1325</pages><issn>1522-8517</issn><eissn>1523-5866</eissn><abstract>p53 is a promising target in human cancer. p28 is a cell-penetrating peptide that preferentially enters cancer cells and binds to both wild-type and mutant p53 protein, inhibiting COP1-mediated ubiquitination and proteasomal degradation. This results in increased levels of p53, which induces cell cycle arrest at G2/M. We conducted a phase I study to determine the maximum-tolerated dose (MTD) and describe the dose-limiting toxicities (DLTs) and pharmacokinetics (PKs) of p28 in children.
Children aged 3-21 years with recurrent or progressive central nervous system tumors were eligible. Intravenous p28 was administered 3 times weekly for 4 consecutive weeks of a 6-week cycle at 4.16 mg/kg/dose (the adult recommended phase II dose) using a rolling-6 study design. Expression status of p53 was characterized by immunohistochemistry, and serum PK parameters were established on the second dose.
Of the 18 eligible patients enrolled in the study, 12 completed the DLT monitoring period and were evaluable for toxicity. p28 was well-tolerated; 7 participants received ≥2 courses, and the most common adverse event attributed to the drug was transient grade 1 infusion-related reaction. PK analysis revealed a profile similar to adults; however, an increased area under the curve was observed in pediatric patients. High p53 expression in tumor cell nuclei was observed in 6 of 12 available tissue samples. There were no objective responses; 2 participants remained stable on the study for >4 cycles.
This phase I study demonstrated that p28 is well-tolerated in children with recurrent CNS malignancies at the adult recommended phase II dose.</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>27022131</pmid><doi>10.1093/neuonc/now047</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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source | Oxford University Press Journals All Titles (1996-Current); MEDLINE; EZB-FREE-00999 freely available EZB journals; PubMed Central |
subjects | Adolescent Adult Antineoplastic Agents - pharmacokinetics Antineoplastic Agents - therapeutic use Azurin - pharmacokinetics Azurin - therapeutic use Central Nervous System Neoplasms - drug therapy Central Nervous System Neoplasms - metabolism Central Nervous System Neoplasms - pathology Child Child, Preschool Clinical Investigation Dose-Response Relationship, Drug Female Follow-Up Studies Humans Male Maximum Tolerated Dose Neoplasm Recurrence, Local - drug therapy Neoplasm Recurrence, Local - metabolism Neoplasm Recurrence, Local - pathology Neoplasm Staging Peptide Fragments - pharmacokinetics Peptide Fragments - therapeutic use Prognosis Tumor Suppressor Protein p53 - metabolism Ubiquitination - drug effects Young Adult |
title | Phase I trial of p28 (NSC745104), a non-HDM2-mediated peptide inhibitor of p53 ubiquitination in pediatric patients with recurrent or progressive central nervous system tumors: A Pediatric Brain Tumor Consortium Study |
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