Vis enkel innførsel

dc.contributor.authorJakola, Asgeir S.
dc.contributor.authorWerlenius, Katja
dc.contributor.authorMudaisi, Munila
dc.contributor.authorHylin, Sofia
dc.contributor.authorKinhult, Sara
dc.contributor.authorbartek, Jiri Jr.
dc.contributor.authorSalvesen, Øyvind
dc.contributor.authorCarlsen, Sven Magnus
dc.contributor.authorStrandeus, Michael
dc.contributor.authorLindskog, Magnus
dc.contributor.authorLofgren, David
dc.contributor.authorRydenhaug, Bertil
dc.contributor.authorCarstam, Louise
dc.contributor.authorGulati, Sasha
dc.contributor.authorSolheim, Ole
dc.contributor.authorBartek, Jiri
dc.contributor.authorSolheim, Tora Skeidsvoll
dc.date.accessioned2019-01-24T08:39:22Z
dc.date.available2019-01-24T08:39:22Z
dc.date.created2019-01-17T09:35:35Z
dc.date.issued2018
dc.identifier.issn2046-1402
dc.identifier.urihttp://hdl.handle.net/11250/2582066
dc.description.abstractBackground: Disulfiram (DSF) is a well-tolerated, inexpensive, generic drug that has been in use to treat alcoholism since the 1950s. There is now independent preclinical data that supports DSF as an anticancer agent, and experimental data suggest that copper may increase its anti-neoplastic properties. There is also some clinical evidence that DSF is a promising anticancer agent in extracranial cancers. In glioblastoma, DSF induced O6-methylguanine methyltransferase (MGMT) inhibition may increase response to alkylating chemotherapy. A recent phase I study demonstrated the safety of DSF in glioblastoma patients when DSF was administered at doses below 500 mg/day together with chemotherapy. We plan to assess the effects of DSF combined with nutritional copper supplement (DSF-Cu) as an adjuvant to alkylating chemotherapy in glioblastoma treatment. Methods: In an academic, industry independent, multicenter, open label randomized controlled phase II/III trial with parallel group design (1:1) we will assess the efficacy and safety of DSF-Cu in glioblastoma treatment. The study will include 142 patients at the time of first recurrence of glioblastoma where salvage therapy with alkylating chemotherapy is planned. Patients will be randomized to treatment with or without DSF-Cu. Primary end-point is survival at 6 months. Secondary end-points are overall survival, progression free survival, quality of life, contrast enhancing tumor volume and safety. Discussion: There is a need to improve the treatment of recurrent glioblastoma. Results from this randomized controlled trial with DSF-Cu in glioblastoma will serve as preliminary evidence of the future role of DSF-Cu in glioblastoma treatment and a basis for design and power estimations of future studies. In this publication we provide rationale for our choices and discuss methodological issues. Trial registration: The study underwent registration in EudraCT 2016-000167-16 (Date: 30.03.2016,) and Clinicaltrials.gov NCT02678975 (Date: 31.01.2016) before initiating the study.nb_NO
dc.language.isoengnb_NO
dc.publisherF1000 Research Ltd.nb_NO
dc.rightsNavngivelse 4.0 Internasjonal*
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/deed.no*
dc.titleDisulfiram repurposing combined with nutritional copper supplement as add-on to chemotherapy in recurrent glioblastoma (DIRECT): Study protocol for a randomized controlled trialnb_NO
dc.typeJournal articlenb_NO
dc.typePeer reviewednb_NO
dc.description.versionpublishedVersionnb_NO
dc.source.volume7nb_NO
dc.source.journalF1000 Researchnb_NO
dc.identifier.doi10.12688/f1000research.16786.1
dc.identifier.cristin1658897
dc.description.localcodeCopyright: © 2018 Jakola AS et al. This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.nb_NO
cristin.unitcode194,65,1,0
cristin.unitcode194,65,30,0
cristin.unitcode194,65,15,0
cristin.unitnameMH fakultetsadministrasjon
cristin.unitnameInstitutt for nevromedisin og bevegelsesvitenskap
cristin.unitnameInstitutt for klinisk og molekylær medisin
cristin.ispublishedtrue
cristin.fulltextoriginal
cristin.qualitycode1


Tilhørende fil(er)

Thumbnail

Denne innførselen finnes i følgende samling(er)

Vis enkel innførsel

Navngivelse 4.0 Internasjonal
Med mindre annet er angitt, så er denne innførselen lisensiert som Navngivelse 4.0 Internasjonal