Evidence map›Paper›PMID 31823832›Full record

Trial reportClinical epigenetics2019

Phase I/II intra-patient dose escalation study of vorinostat in children with relapsed solid tumor, lymphoma, or leukemia.

Cornelis M van Tilburg, Till Milde, Ruth Witt, Jonas Ecker, Thomas Hielscher, Angelika Seitz, Jens-Peter Schenk, Juliane L Buhl, Dennis Riehl, Michael C Frühwald and 17 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Clinical epigenetics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01422499 (Phase I/II Intra-patient Dose Escalation Study of Vorinostat in Children With Relapsed Solid Tumor, Lymphoma or Leukemia), which is not on this map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 17% 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.

NCT01422499 phase1 / phase2completednot on this map

Phase I/II Intra-patient Dose Escalation Study of Vorinostat in Children With Relapsed Solid Tumor, Lymphoma or Leukemia

TypeinterventionalSponsorNational Center for Tumor Diseases, HeidelbergRan2012 to 2017Enrolled50ConditionsChildren With Relapsed Solid Tumor, Lymphoma or LeukemiaArmszolinza/vorinostat
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 1 synthesis or guideline pooled it, 44 citations in OpenAlex.

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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

27 authors at 9 institutions in 1 country.

Cornelis M van TilburgKiTZ Clinical Trial Unit, Hopp Children's Cancer Center Heidelberg (KiTZ), German Cancer Research Center (DKFZ) and Heidelberg University Hospital, Im Neuenheimer Feld 430, 69120, Heidelberg, Germany.ORCID 0000-0001-5274-910X
Till MildeKiTZ Clinical Trial Unit, Hopp Children's Cancer Center Heidelberg (KiTZ), German Cancer Research Center (DKFZ) and Heidelberg University Hospital, Im Neuenheimer Feld 430, 69120, Heidelberg, Germany.
Ruth WittKiTZ Clinical Trial Unit, Hopp Children's Cancer Center Heidelberg (KiTZ), German Cancer Research Center (DKFZ) and Heidelberg University Hospital, Im Neuenheimer Feld 430, 69120, Heidelberg, Germany.
Jonas EckerKiTZ Clinical Trial Unit, Hopp Children's Cancer Center Heidelberg (KiTZ), German Cancer Research Center (DKFZ) and Heidelberg University Hospital, Im Neuenheimer Feld 430, 69120, Heidelberg, Germany.
Thomas HielscherDivision of Biostatistics, German Cancer Research Center (DKFZ) and German Consortium for Translational Cancer Research (DKTK), Heidelberg, Germany.
Angelika SeitzDivision of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany.
Jens-Peter SchenkDivision of Pediatric Radiology, Heidelberg University Hospital, Heidelberg, Germany.
Juliane L BuhlKiTZ Clinical Trial Unit, Hopp Children's Cancer Center Heidelberg (KiTZ), German Cancer Research Center (DKFZ) and Heidelberg University Hospital, Im Neuenheimer Feld 430, 69120, Heidelberg, Germany.
Dennis RiehlDKTK Immune Monitoring Unit, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT), Heidelberg, Germany.
Michael C FrühwaldSwabian Children's Cancer Center, University Children's Hospital Augsburg, Augsburg, Germany.
Arnulf PekrunChildren's Hospital, Bremen, Germany.
Claudia RossigDepartment of Pediatric Hematology and Oncology, University Children's Hospital Muenster, Muenster, Germany.
Regina WielandDepartment of Pediatric Oncology and Hematology, Essen University Hospital, Essen, Germany.
Christian FlothoDivision of Pediatric Oncology and Hematology, Freiburg University Hospital, Freiburg, Germany.
Uwe KordesDepartment of Pediatric Hematology and Oncology, University Medical Center Eppendorf, Hamburg, Germany.
Bernd GruhnDepartment of Pediatrics, Jena University Hospital, Jena, Germany.
Thorsten SimonDepartment of Pediatric Oncology and Hematology, Cologne University Hospital, Cologne, Germany.
Christin LinderkampDepartment of Pediatric Oncology and Hematology, Hannover University Hospital, Hanover, Germany.
Felix SahmClinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ) and German Consortium for Translational Cancer Research (DKTK), Heidelberg, Germany.
Lenka TaylorPharmacy Department, Heidelberg University Hospital, Heidelberg, Germany.
Angelika FreitagNCT Trial Center, National Center for Tumor Diseases, German Cancer Research Center (DKFZ), Heidelberg, Germany.
Jürgen BurhenneDepartment of Clinical Pharmacology and Pharmacoepidemiology, Heidelberg University Hospital, Heidelberg, Germany.
Kathrin I FoersterDepartment of Clinical Pharmacology and Pharmacoepidemiology, Heidelberg University Hospital, Heidelberg, Germany.
Andreas D MeidDepartment of Clinical Pharmacology and Pharmacoepidemiology, Heidelberg University Hospital, Heidelberg, Germany.
Stefan M PfisterKiTZ Clinical Trial Unit, Hopp Children's Cancer Center Heidelberg (KiTZ), German Cancer Research Center (DKFZ) and Heidelberg University Hospital, Im Neuenheimer Feld 430, 69120, Heidelberg, Germany.
Irini Karapanagiotou-SchenkelNCT Trial Center, National Center for Tumor Diseases, German Cancer Research Center (DKFZ), Heidelberg, Germany.
Olaf WittKiTZ Clinical Trial Unit, Hopp Children's Cancer Center Heidelberg (KiTZ), German Cancer Research Center (DKFZ) and Heidelberg University Hospital, Im Neuenheimer Feld 430, 69120, Heidelberg, Germany. o.witt@kitz-heidelberg.de.
German Cancer Research Center · DEHeidelberg University · DEEssen University Hospital · DEJena University Hospital · DEUniversität Hamburg · DEUniversity Hospital Augsburg · DEUniversity Hospital Cologne · DEUniversity Hospital Münster · DEUniversity Medical Center Freiburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundUntil today, adult and pediatric clinical trials investigating single-agent or combinatorial HDAC inhibitors including vorinostat in solid tumors have largely failed to demonstrate efficacy. These results may in part be explained by data from preclinical models showing significant activity only at higher concentrations compared to those achieved with current dosing regimens. In the current pediatric trial, we applied an intra-patient dose escalation design. The purpose of this trial was to determine a safe dose recommendation (SDR) of single-agent vorinostat for intra-patient dose escalation, pharmacokinetic analyses (PK), and activity evaluation in children (3-18 years) with relapsed or therapy-refractory malignancies.

resultsA phase I intra-patient dose (de)escalation was performed until individual maximum tolerated dose (MTD). The starting dose was 180 mg/m

conclusionAn SDR of 130 mg/m

trial registrationClinicalTrials.gov, NCT01422499. Registered 24 August 2011.

Indexed as

AdolescentChildChild, PreschoolDrug Administration ScheduleFemaleHistone Deacetylase InhibitorsHumansLeukemiaLymphomaMaleMaximum Tolerated DoseNeoplasm Recurrence, LocalNeoplasmsSurvival AnalysisTreatment OutcomeVorinostatHistone Deacetylase InhibitorsVorinostatChildCytokineDose-responseHDACIntra-patient dose escalationVorinostat

Identifiers

PMID31823832
PMCPMC6902473
OpenAlexW2994990079

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Registered trials

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.