Evidence map›Paper›PMID 33604574›Full record

ArticleNeuro-oncology advances

Phase I trial of intranasal NEO100, highly purified perillyl alcohol, in adult patients with recurrent glioblastoma.

Axel H Schönthal, David M Peereboom, Naveed Wagle, Rose Lai, Anna J Mathew, Kyle M Hurth, Vincent F Simmon, Steven P Howard, Lynne P Taylor, Frances Chow and 2 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
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 NCT02704858 (An Open-Label, Phase 1/2A Dose Escalation Study of Safety and Efficacy of NEO100 in Recurrent or Progressive Grade III or Grade IV Gliomas With IDH1 Mutation), which is not on this map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
2.8field-weighted citation impact, top 9% 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.

NCT02704858 phase1 / phase2active not recruitingnot on this map

An Open-Label, Phase 1/2A Dose Escalation Study of Safety and Efficacy of NEO100 in Recurrent or Progressive Grade III or Grade IV Gliomas With IDH1 Mutation

TypeinterventionalSponsorNeonc Technologies, Inc.Ran2017 to 2026Enrolled49ConditionsGlioblastoma MultiformeArmsPerillyl alcohol
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 34 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

12 authors at 7 institutions in 2 countries.

Axel H SchönthalDepartment of Molecular Microbiology and Immunology, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.
David M PeereboomDepartment of Medical Oncology, Cleveland Clinic, Cleveland, Ohio, USA.
Naveed WagleDepartment of Oncology, Providence St. Johns Medical Center, Santa Monica, California, USA.
Rose LaiDepartment of Neurology, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.
Anna J MathewDepartment of Pathology, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.
Kyle M HurthDepartment of Pathology, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.
Vincent F SimmonNeOnc Technologies, Inc., Los Angeles, California, USA.
Steven P HowardDepartment of Radiation Oncology, University of Wisconsin, Madison, Wisconsin, USA.
Lynne P TaylorDepartment of Medicine, University of Washington, Seattle, Washington, USA.
Frances ChowDepartment of Neurology, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.
Clovis O da FonsecaNeOnc Technologies, Inc., Los Angeles, California, USA.
Thomas C ChenDepartment of Pathology, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.
University of Southern California · USCleveland Clinic · USHospital Universitário Antônio Pedro · BRNesher Technologies (United States) · USSaint John's Health Center · USUniversity of Washington · USUniversity of Wisconsin–Madison · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBetter treatments for glioblastoma (GBM) patients, in particular in the recurrent setting, are urgently needed. Clinical trials performed in Brazil indicated that intranasal delivery of perillyl alcohol (POH) might be effective in this patient group. NEO100, a highly purified version of POH, was current good manufacturing practice (cGMP) manufactured to evaluate the safety and efficacy of this novel approach in a Phase I/IIa clinical trial in the United States.

methodsA total of 12 patients with recurrent GBM were enrolled into Phase I of this trial. NEO100 was administered by intranasal delivery using a nebulizer and nasal mask. Dosing was 4 times a day, every day. Four cohorts of 3 patients received the following dosages: 96 mg/dose (384 mg/day), 144 mg/dose (576 mg/day), 192 mg/dose (768 mg/day), and 288 mg/dose (1152 mg/day). Completion of 28 days of treatment was recorded as 1 cycle. Adverse events were documented, and radiographic response

resultsIntranasal NEO100 was well tolerated at all dose levels and no severe adverse events were reported. PFS-6 was 33%, OS-12 was 55%, and median OS was 15 months. Four patients (33%), all of them with isocitrate dehydrogenase 1 (IDH1)-mutant tumors, survived >24 months.

conclusionIntranasal glioma therapy with NEO100 was well tolerated. It correlated with improved survival when compared to historical controls, pointing to the possibility that this novel intranasal approach could become useful for the treatment of recurrent GBM.

Indexed as

intranasalisocitrate dehydrogenase 1O6-methylguanine-DNA methyltransferaseperillyl alcoholrecurrent glioblastoma

Identifiers

PMID33604574
PMCPMC7879254
OpenAlexW3131336574

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

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.