Evidence map›Paper›PMID 32666050›Full record

ArticleNeuro-oncology advances

Phase I study of vinblastine in combination with nilotinib in children, adolescents, and young adults with refractory or recurrent low-grade glioma.

Stephanie Vairy, Gwénaël Le Teuff, Francisco Bautista, Emilie De Carli, Anne-Isabelle Bertozzi, Anne Pagnier, Fanny Fouyssac, Karsten Nysom, Isabelle Aerts, Pierre Leblond and 15 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Neuro-oncology advances. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01884922 (PHASE I-II STUDY OF VINBLASTINE IN COMBINATION WITH NILOTINIB IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS WITH REFRACTORY OR RECURRENT LOW-GRADE GLIOMA), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.4field-weighted citation impact, top 38% 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.

NCT01884922 phase1completednot on this map

Phase i-ii study of vinblastine in combination with nilotinib in children, adolescents, and young adults with refractory or recurrent low-grade glioma

TypeinterventionalSponsorGustave Roussy, Cancer Campus, Grand ParisRan2013 to 2016Enrolled35ConditionsRefractory Low-grade Gliomas, Recurrent Low-grade GliomasArmsNilotinib, Vinblastine
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 7 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

25 authors at 13 institutions in 2 countries.

Stephanie VairyDepartment of Pediatric and Adolescent Oncology, Gustave Roussy, Villejuif, France.ORCID 0000-0001-8107-9969
Gwénaël Le TeuffUniversité Paris-Saclay, Université Paris-Sud, UVSQ, CESP, INSERM, Villejuif, France.
Francisco BautistaDepartment of Pediatric and Adolescent Oncology, Gustave Roussy, Villejuif, France.
Emilie De CarliDépartement d'Hematologie et d'Oncologie Pediatrique, Centre Hospitalier Universitaire d'Angers, Angers, France.
Anne-Isabelle BertozziDépartement d'Hematologie et d'Oncologie Pediatrique, Hopital Purpan, Centre Hospitalier Universitaire de Toulouse, Toulouse, France.
Anne PagnierDépartement d'Hematologie et d'Oncologie Pediatrique, Centre Hospitalier Universitaire de Grenoble, La Tronche, France.
Fanny FouyssacDépartement d'Hematologie et d'Oncologie Pediatrique, Centre Hospitalier Universitaire de Nancy, Nancy, France.
Karsten NysomDepartment of Pediatric Hematology and Oncology, Rigshospitalet, Copenhagen, Denmark.
Isabelle AertsSIREDO Center, Institut Curie, Paris, France.
Pierre LeblondUnité d'oncologie pédiatrique, Centre Oscar Lambret, Lille, France.ORCID 0000-0002-7088-2614
Frederic MillotDépartement d'Hematologie et d'Oncologie Pediatrique, Centre Hospitalier Universitaire de Poitiers, Poitiers, France.
Claire BergerDépartement d'Hematologie et d'Oncologie Pediatrique, Centre Hospitalier Universitaire de Saint-Etienne, Saint-Priest-en-Jarez, France.
Sandra CanaleDepartment of Radiology, Gustave Roussy, Villejuif, France.
Angelo PaciDepartment of Pharmacology and Pharmacokinetics Unit School of Pharmacy, Université Paris-Saclay, Université Paris-Sud, Gustave Roussy, Villejuif, France.
Vianney PoinsignonDepartment of Pharmacology and Pharmacokinetics Unit School of Pharmacy, Université Paris-Saclay, Université Paris-Sud, Gustave Roussy, Villejuif, France.
Aurelie ChevanceUniversité Paris-Saclay, Université Paris-Sud, UVSQ, CESP, INSERM, Villejuif, France.
Monia EzzalfaniUniversité Paris-Saclay, Université Paris-Sud, UVSQ, CESP, INSERM, Villejuif, France.
Dominique VidaudService de Génétique et Biologie Moléculaires, Hopital Cochin, Hopitaux Universitaires de Paris Centre, Assistance Publique-Hôpitaux de Paris, and EA7331, Faculte de Pharmacie de Paris, Universite Paris Descartes, Paris, France.
Angela Di GiannataleDepartment of Pediatric and Adolescent Oncology, Gustave Roussy, Villejuif, France.
Raquel Hladun-AlvaroDepartment of Pediatric and Adolescent Oncology, Gustave Roussy, Villejuif, France.
Francois M PetitDépartement de Génétique Moléculaire, Hopital Antoine Beclere, Clamart, France.
Gilles VassalDepartment of Pediatric and Adolescent Oncology, Gustave Roussy, Villejuif, France.
Birgit GeoergerDepartment of Pediatric and Adolescent Oncology, Gustave Roussy, Villejuif, France.
Marie-Cécile Le DeleyUniversité Paris-Saclay, Université Paris-Sud, UVSQ, CESP, INSERM, Villejuif, France.
Jacques GrillDepartment of Pediatric and Adolescent Oncology, Gustave Roussy, Villejuif, France.
Institut Gustave Roussy · FRUniversité Paris-Sud · FRCentre Hospitalier Régional et Universitaire de Nancy · FRCentre Hospitalier Universitaire d'Angers · FRCentre Hospitalier Universitaire de Grenoble · FRCentre Hospitalier Universitaire de Poitiers · FRCentre Hospitalier Universitaire de Saint-Étienne · FRCentre Hospitalier Universitaire de Toulouse · FRCentre Oscar Lambret · FRHôpital Antoine-Béclère · FRInstitut Curie · FRRigshospitalet · DKUniversité Paris Cité · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNew rescue regimens are needed for pediatric refractory/recurrent low-grade glioma. Nilotinib is a tyrosine kinase inhibitor that has potential synergistic effects with vinblastine on angiogenesis, tumor cell growth, and immunomodulation.

methodsThis phase I trial aimed to determine the recommended doses of this combination for phase II trials (RP2D) using the dual-agent Bayesian continual reassessment method. Nilotinib was given orally twice daily (BID) in combination with once-weekly vinblastine injections for a maximum of 12 cycles of 28 days (clinicaltrials.gov, NCT01884922).

resultsThirty-five pediatric patients were enrolled across 4 dose levels. The median age was 7 years and 10 had neurofibromatosis type 1. Patients had received a median of 3 prior treatment lines and 25% had received more than 4 previous treatment lines. Dose-limiting toxicity (DLT) during cycle 1 was hematologic, dermatologic, and cardiovascular. The RP2D was identified at 3 mg/m

conclusionsVinblastine and nilotinib combination was mostly limited by myelosuppression and dermatologic toxicity. The efficacy of the combination at the RP2D is currently evaluated in a randomized phase II trial comparing this regimen to vinblastine alone.

Indexed as

Gilbert diseaseneurofibromatosis type 1pharmacogenomicspharmacokineticspilocytic astrocytoma

Identifiers

PMID32666050
PMCPMC7344116
OpenAlexW3034431925

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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.