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Disulfiram repurpos...
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Jakola, Asgeir StoreGothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för klinisk neurovetenskap,Institute of Neuroscience and Physiology, Department of Clinical Neuroscience
(author)
Disulfiram repurposing combined with nutritional copper supplement as add-on to chemotherapy in recurrent glioblastoma (DIRECT) : Study protocol for a randomized controlled trial
- Article/chapterEnglish2018
Publisher, publication year, extent ...
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2018-11-15
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F1000Research,2018
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printrdacarrier
Numbers
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LIBRIS-ID:oai:DiVA.org:oru-101863
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https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-101863URI
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https://doi.org/10.12688/f1000research.16786.1DOI
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http://kipublications.ki.se/Default.aspx?queryparsed=id:230647912URI
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https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-464976URI
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https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-156059URI
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https://gup.ub.gu.se/publication/276722URI
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https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-464974URI
Supplementary language notes
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Language:English
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Summary in:English
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Subject category:ref swepub-contenttype
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Subject category:art swepub-publicationtype
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Background: 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 O 6-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.
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Werlenius, KatjaGothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för onkologi,Institute of Clinical Sciences, Department of Oncology(Swepub:gu)xwerka
(author)
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Mudaisi, MunilaLinköpings universitet,Karolinska Institutet,Avdelningen för Kirurgi, Ortopedi och Onkologi,Medicinska fakulteten,Region Östergötland, Onkologiska kliniken US(Swepub:liu)munmu89
(author)
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Hylin, SofiaDepartment of Neurology, Karolinska University Hospital, Stockholm, Sweden
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Kinhult, SaraDepartment of Oncology, Skåne University Hospital, Lund, Sweden
(author)
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Bartek Jr., JiriKarolinska Institutet,Department of Neurosurgery, Karolinska University Hospital, Stockholm, Sweden; Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden,Department of Medical Biochemistry and Biophysics, Division of Genome Biology, Science for Life Laboratory,, Karolinska Institute, Stockholm, Sweden; Research Center, Danish Cancer Society, Copenhagen, Denmark
(author)
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Salvesen, ØyvindDepartment of Public Health and Nursing, Norwegian University of Science and Technology, Trondheim, Norway
(author)
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Carlsen, Sven MagnusDepartment of Cancer Research and Molecular medicine, Norwegian University of Science and Technology, Trondheim, Norway; Department of Endocrinology, St. Olavs Hospital, Trondheim, Norway
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Strandéus, MichaelDepartment of Oncology, County Hospital Ryhov, Jönköping, Sweden
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Lindskog, MagnusUppsala universitet,Klinisk och experimentell patologi,Cancerfarmakologi och beräkningsmedicin,Experimentell och klinisk onkologi,Department of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden; Section of Oncology, Akademiska University Hospital, Uppsala, Sweden(Swepub:uu)magli409
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Löfgren, David,1977-Department of Oncology, Örebro University Hospital, Örebro, Sweden(Swepub:oru)dln
(author)
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Rydenhag, Bertil,1954Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi,Institute of Neuroscience and Physiology(Swepub:gu)xrydbe
(author)
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Carstam, LouiseGothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för klinisk neurovetenskap,Institute of Neuroscience and Physiology, Department of Clinical Neuroscience(Swepub:gu)xcarsl
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Gulati, SashaDepartment of Neurosurgery, St. Olavs Hospital, Trondheim, Norway; Department of Neuroscience, Norwegian University of Science and Technology, Trondheim, Norway
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Solheim, OleDepartment of Neurosurgery, St. Olavs Hospital, Trondheim, Norway; Department of Neuroscience, Norwegian University of Science and Technology, Trondheim, Norway
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Bartek, JiriDepartment of Medical Biochemistry and Biophysics, Division of Genome Biology, Science for Life Laboratory,, Karolinska Institute, Stockholm, Sweden; Research Center, Danish Cancer Society, Copenhagen, Denmark
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Solheim, ToraEuropean Palliative Care Research Centre (PRC), Department of Cancer Research and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway; Cancer Clinic, St. Olavs Hospital, Trondheim, Norway
(author)
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Göteborgs universitetInstitutionen för neurovetenskap och fysiologi, sektionen för klinisk neurovetenskap
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Jakola, Asgeir S ...
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Werlenius, Katja
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Mudaisi, Munila
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Hylin, Sofia
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Kinhult, Sara
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Bartek Jr., Jiri
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Salvesen, Øyvind
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Carlsen, Sven Ma ...
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Strandéus, Micha ...
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Lindskog, Magnus
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Löfgren, David, ...
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Rydenhag, Bertil ...
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Carstam, Louise
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Gulati, Sasha
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Solheim, Ole
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Bartek, Jiri
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Solheim, Tora
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