Evidence map›Paper›PMID 26554649›Full record

ArticleBritish journal of cancer2015

Phase I trial of EpCAM-targeting immunotoxin MOC31PE, alone and in combination with cyclosporin.

Y Andersson, O Engebraaten, S Juell, S Aamdal, P Brunsvig, Ø Fodstad, S Dueland

Open access · hybridAbstract readClinical Trial, Phase I
In one paragraph

Article in British journal of cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
1.2field-weighted citation impact, top 21% 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

21 citing papers in PubMed, 34 citations in OpenAlex.

  1. Review
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  9. Article
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  12. Review
  13. Immunogenicity of Immunotoxins ContainingFrontiers in immunology · 2020
    Review
  14. Toxins · 2019
    Review
  15. Article
  16. The expansion of targetable biomarkers for CAR T cell therapy.Journal of experimental & clinical cancer research : CR · 2018
    Review
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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

7 authors at 3 institutions in 1 country.

Y AnderssonDepartment of Tumor Biology, Institute for Cancer Research, Oslo University Hospital Radiumhospitalet, 0424 Oslo, Norway.
O EngebraatenDepartment of Tumor Biology, Institute for Cancer Research, Oslo University Hospital Radiumhospitalet, 0424 Oslo, Norway.
S JuellDepartment of Tumor Biology, Institute for Cancer Research, Oslo University Hospital Radiumhospitalet, 0424 Oslo, Norway.
S AamdalInstitute of Clinical Medicine, Faculty of Medicine, University of Oslo, 0424 Oslo, Norway.
P BrunsvigDepartment of Clinical Cancer Research, Oslo University Hospital Radiumhospitalet, 0424 Oslo, Norway.
Ø FodstadDepartment of Tumor Biology, Institute for Cancer Research, Oslo University Hospital Radiumhospitalet, 0424 Oslo, Norway.
S DuelandDepartment of Oncology, Oslo University Hospital, 0424 Oslo, Norway.
Oslo University Hospital · NONorwegian Cancer Society · NOUniversity of Oslo · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA phase I trial was performed to determine the maximum tolerated dose (MTD), safety, pharmacokinetics and immunogenicity of the anti-EpCAM immunotoxin (IT) MOC31PE in cancer patients. An important part of the study was to investigate whether the addition of Sandimmune (cyclosporin, CsA) suppressed the development of anti-IT antibodies.

methodsPatients with EpCAM-positive metastatic disease were eligible for treatment with intravenous MOC31PE using a modified Fibonacci dose escalation sequence. Maximum tolerated dose was first established without, then with intravenously administered CsA.

resultsSixty-three patients were treated with MOC31PE in doses ranging from 0.5 to 8 μg kg(-1). Maximum tolerated dose was 8 μg kg(-1) for MOC31PE alone, and 6.5 μg kg(-1) when combined with CsA. The dose-limiting adverse event was reversible liver toxicity. No radiological complete or partial responses were observed, whereas stable disease was seen in 36% of the patients receiving MOC31PE only. The pharmacokinetic profile of MOC31PE was characterised by linear kinetics and with a half-life of ∼3 h. The addition of CsA delayed the generation of anti-IT antibodies.

conclusionsIntravenous infusion of MOC31PE can safely be administered to cancer patients. Immune suppression with CsA delays the development of anti-MOC31PE antibodies. The antitumour effect of MOC31PE warrants further evaluation in EpCAM-positive metastatic disease.

Indexed as

AdultAgedAlanine TransaminaseAnimalsAntigens, NeoplasmAntineoplastic Combined Chemotherapy ProtocolsAspartate AminotransferasesBone Marrow NeoplasmsCarcinomaCell Adhesion MoleculesChemical and Drug Induced Liver InjuryCyclosporineDrug InteractionsEpithelial Cell Adhesion MoleculeFemaleHalf-LifeAlanine TransaminaseAntigens, NeoplasmAspartate AminotransferasesCell Adhesion MoleculesCyclosporineEpithelial Cell Adhesion MoleculeImmunoconjugatesMOC31PE immunotoxin

Identifiers

PMID26554649
PMCPMC4705890
OpenAlexW2228194427

What OpenQuestion holds

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LicenceCC BY-NC-SA
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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.