Evidence map›Paper›PMID 30771200›Full record

Trial reportJournal of neuro-oncology2019

A multicenter phase II study of temozolomide plus disulfiram and copper for recurrent temozolomide-resistant glioblastoma.

Jiayi Huang, Rekha Chaudhary, Adam L Cohen, Karen Fink, Samuel Goldlust, John Boockvar, Prakash Chinnaiyan, Leping Wan, Stephen Marcus, Jian L Campian

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Journal of neuro-oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 75 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
75citing papers in PubMed, 2 pooled it
15.8field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

75 citing papers in PubMed, 2 syntheses or guidelines pooled it, 125 citations in OpenAlex.

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15 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 7 institutions in 2 countries.

Jiayi HuangWashington University School of Medicine, St. Louis, MO, USA. jiayi.huang@wustl.edu.ORCID http://orcid.org/0000-0002-5153-506X
Rekha ChaudharyUniversity of Cincinnati College of Medicine, Cincinnati, OH, USA.
Adam L CohenHuntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.
Karen FinkBaylor University Medical Center, Dallas, TX, USA.
Samuel GoldlustHackensack University Medical Center, Hackensack, NJ, USA.
John BoockvarLenox Hill Hospital, New York, NY, USA.
Prakash ChinnaiyanBeaumont Health, Royal Oak, MI, USA.
Leping WanWashington University School of Medicine, St. Louis, MO, USA.
Stephen MarcusCantex Pharmaceuticals, Weston, FL, USA.
Jian L CampianWashington University School of Medicine, St. Louis, MO, USA.
Washington University in St. Louis · USBaylor University Medical Center · USBeaumont Health · USHackensack University Medical Center · USLenox Hill Hospital · USUniversity of Cincinnati Medical Center · USUniversity of Utah · US

Funding

Cantex Pharmaceuticals NA
6 · The paper itself

Abstract

purposePreclinical studies have suggested promising activity for the combination of disulfiram and copper (DSF/Cu) against glioblastoma (GBM) including re-sensitization to temozolomide (TMZ). A previous phase I study demonstrated the safety of combining DSF/Cu with adjuvant TMZ for newly diagnosed GBM. This phase II study aimed to estimate the potential effectiveness of DSF/Cu to re-sensitize recurrent GBM to TMZ.

methodsThis open-label, single-arm phase II study treated recurrent TMZ-resistant GBM patients with standard monthly TMZ plus concurrent daily DSF 80 mg PO TID and Cu 1.5 mg PO TID. Eligible patients must have progressed after standard chemoradiotherapy and within 3 months of the last dose of TMZ. Known isocitrate dehydrogenase (IDH) mutant or secondary GBMs were excluded. The primary endpoint was objective response rate (ORR), and the secondary endpoints included progression-free survival (PFS), overall survival (OS), clinical benefit (response or stable disease for at least 6 months), and safety.

resultsFrom March 2017 to January 2018, 23 recurrent TMZ-resistant GBM patients were enrolled across seven centers, and 21 patients were evaluable for response. The median duration of DSF/Cu was 1.6 cycles (range: 0.1-12.0). The ORR was 0%, but 14% had clinical benefit. Median PFS was 1.7 months, and median OS was 7.1 months. Only one patient (4%) had dose-limiting toxicity (grade three elevated alanine transaminase).

conclusionsAddition of DSF/Cu to TMZ for TMZ-resistant IDH-wild type GBM appears well tolerated but has limited activity for unselected population.

Indexed as

Acetaldehyde Dehydrogenase InhibitorsAdultAgedAntineoplastic Agents, AlkylatingAntineoplastic Combined Chemotherapy ProtocolsBrain NeoplasmsCopperDisulfiramDrug Resistance, NeoplasmDrug Therapy, CombinationFemaleFollow-Up StudiesGlioblastomaHumansMaleNeoplasm Recurrence, LocalAcetaldehyde Dehydrogenase InhibitorsAntineoplastic Agents, AlkylatingCopperDisulfiramTemozolomideTrace ElementsClinical trialCopperDisulfiramRecurrent glioblastomaTemozolomide

Identifiers

PMID30771200
OpenAlexW2912845066

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.