Evidence map›Paper›PMID 33135391›Full record

ArticleCancer medicine2021

A phase 1 study of combined guadecitabine and cisplatin in platinum refractory germ cell cancer.

Costantine Albany, Zeeshan Fazal, Ratnakar Singh, Emmanuel Bikorimana, Nabil Adra, Nasser H Hanna, Lawrence H Einhorn, Susan M Perkins, George E Sandusky, Brock C Christensen and 4 more

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

Article in Cancer medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed
4.7field-weighted citation impact, top 4% 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

28 citing papers in PubMed, 36 citations in OpenAlex.

  1. Article
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  7. Epigenetics-targeted drugs: current paradigms and future challenges.Signal transduction and targeted therapy · 2024
    Review
  8. Article
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  10. Role of Epigenetics for the Efficacy of Cisplatin.International journal of molecular sciences · 2024
    Review
  11. Article
  12. Article
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  15. Epigenetic Regulation of Driver Genes in Testicular Tumorigenesis.International journal of molecular sciences · 2023
    Review
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  19. Article
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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

14 authors at 6 institutions in 1 country.

Costantine AlbanyDivision of Hematology/Oncology, Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indiana University School of Medicine, Indianapolis, IN, USA.
Zeeshan FazalDepartment of Comparative Biosciences and the Cancer Center at Illinois, University of Illinois at Urbana-Champaign, Urbana, IL, USA.
Ratnakar SinghDepartment of Comparative Biosciences and the Cancer Center at Illinois, University of Illinois at Urbana-Champaign, Urbana, IL, USA.ORCID 0000-0002-3226-3847
Emmanuel BikorimanaDepartment of Comparative Biosciences and the Cancer Center at Illinois, University of Illinois at Urbana-Champaign, Urbana, IL, USA.
Nabil AdraDivision of Hematology/Oncology, Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indiana University School of Medicine, Indianapolis, IN, USA.ORCID 0000-0001-8905-8329
Nasser H HannaDivision of Hematology/Oncology, Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indiana University School of Medicine, Indianapolis, IN, USA.
Lawrence H EinhornDivision of Hematology/Oncology, Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indiana University School of Medicine, Indianapolis, IN, USA.
Susan M PerkinsDepartment of Biostatistics, Indiana University School of Medicine, Indianapolis, IN, USA.
George E SanduskyDivision of Hematology/Oncology, Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indiana University School of Medicine, Indianapolis, IN, USA.
Brock C ChristensenDepartment of Epidemiology, Geisel School of Medicine at Dartmouth, Hanover, NH, USA.
Harold KeerAstex Pharmaceuticals, Inc, Pleasanton, CA, USA.
Fang FangMedical Sciences Program, Indiana University School of Medicine, Bloomington, IN, USA.ORCID 0000-0002-7160-5723
Kenneth P NephewMedical Sciences Program, Indiana University School of Medicine, Bloomington, IN, USA.
Michael J SpinellaDepartment of Comparative Biosciences and the Cancer Center at Illinois, University of Illinois at Urbana-Champaign, Urbana, IL, USA.ORCID 0000-0003-3150-3009
Indiana University Health · USUniversity of Illinois Urbana-Champaign · USIndiana University Bloomington · USDartmouth College · USIndiana University School of MedicinePlex Pharmaceuticals (United States) · US

Funding

Translational Engineering in Cancer (TEC)P30CA023108 · NCI · DARTMOUTH COLLEGE · PI Fred W Kolling IV · 1985 to 2026
$91.3M
DNA Methylation Inhibitor Therapy for Testicular CancerR01CA211875 · NCI · UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN · PI SPINELLA, MICHAEL J · 2018 to 2022
$2.5M
A Novel Clinically Relevant Tumor Suppressor in Human Breast CancerR03CA223709 · NCI · UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN · PI SPINELLA, MICHAEL J · 2018 to 2019
$154k
NCI NIH HHS P30 CA023108NCI NIH HHS R01 CA211875NCI NIH HHS R03 CA223709
6 · The paper itself

Abstract

purposeGerm cell tumors (GCTs) are cured with therapy based on cisplatin, although a clinically significant number of patients are refractory and die of progressive disease. Based on preclinical studies indicating that refractory testicular GCTs are hypersensitive to hypomethylating agents (HMAs), we conducted a phase I trial combining the next-generation HMA guadecitabine (SGI-110) with cisplatin in recurrent, cisplatin-resistant GCT patients.

methodsPatients with metastatic GCTs were treated for five consecutive days with guadecitabine followed by cisplatin on day 8, for a 28-day cycle for up to six cycles. The primary endpoint was safety and toxicity including dose-limiting toxicity (DLT) and maximum tolerated dose (MTD).

resultsThe number of patients enrolled was 14. The majority of patients were heavily pretreated. MTD was determined to be 30 mg/m

conclusionsThe combination of guadecitabine and cisplatin was tolerable and demonstrated activity in patients with platinum refractory germ cell cancer.

Indexed as

AdultAntineoplastic Combined Chemotherapy ProtocolsAzacitidineCisplatinDose-Response Relationship, DrugDrug Resistance, NeoplasmHumansIndianaMaleMaximum Tolerated DoseMiddle AgedNeoplasms, Germ Cell and EmbryonalTesticular NeoplasmsTime FactorsTreatment OutcomeYoung AdultAzacitidineCisplatinguadecitabinecisplatinDNA methylationDNA methyltransferaseepigeneticsguadecitabineSGI-110testicular cancer

Identifiers

PMID33135391
PMCPMC7826483
OpenAlexW3095446721

What OpenQuestion holds

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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.