Evidence map›Paper›PMID 35821679›Full record

ArticleNeuro-oncology advances

Phase I trial of sargramostim/pelareorep therapy in pediatric patients with recurrent or refractory high-grade brain tumors.

Matthew R Schuelke, Justin H Gundelach, Matt Coffey, Emma West, Karen Scott, Derek R Johnson, Adel Samson, Alan Melcher, Richard G Vile, Richard J Bram

Open 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. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
3.8field-weighted citation impact, top 6% 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

22 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 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

10 authors at 5 institutions in 3 countries.

Matthew R SchuelkeMedical Scientist Training Program, Mayo Clinic, Rochester, Minnesota, USA.
Justin H GundelachDepartment of Immunology, Mayo Clinic, Rochester, Minnesota, USA.
Matt CoffeyOncolytics Biotech, Calgary, Alberta, Canada.
Emma WestFaculty of Medicine and Health, Leeds Institute of Medical Research, University of Leeds, St James' University Hospital, Leeds, UK.
Karen ScottFaculty of Medicine and Health, Leeds Institute of Medical Research, University of Leeds, St James' University Hospital, Leeds, UK.
Derek R JohnsonDepartment of Radiology, Mayo Clinic, Rochester, Minnesota, USA.
Adel SamsonFaculty of Medicine and Health, Leeds Institute of Medical Research, University of Leeds, St James' University Hospital, Leeds, UK.
Alan MelcherThe Institute of Cancer Research/Royal Marsden, National Institute for Health Research Biomedical Research Centre, London, UK.ORCID https://orcid.org/0000-0002-2042-3380
Richard G VileFaculty of Medicine and Health, Leeds Institute of Medical Research, University of Leeds, St James' University Hospital, Leeds, UK.
Richard J BramDepartment of Immunology, Mayo Clinic, Rochester, Minnesota, USA.
University of Leeds · GBMayo Clinic · USInstitute of Cancer Research · GBMayo Clinic in Florida · USOncolytics Biotech (Canada) · CA

Funding

Women's Cancer ProgramP30CA015083 · NCI · MAYO CLINIC ROCHESTER · PI AKHILESH PANDEY · 1985 to 2026
$151.3M
NCI NIH HHS P30 CA015083
6 · The paper itself

Abstract

Background: Brain tumors are the leading cause of cancer death for pediatric patients. Pelareorep, an immunomodulatory oncolytic reovirus, has intravenous efficacy in preclinical glioma models when preconditioned with GM-CSF (sargramostim). We report a phase I trial with the primary goal of evaluating the safety of sargramostim/pelareorep in pediatric patients with recurrent or refractory high-grade brain tumors and a secondary goal of characterizing immunologic responses. Methods: The trial was open to pediatric patients with recurrent or refractory high-grade brain tumors (3 + 3 cohort design). Each cycle included 3 days of subcutaneous sargramostim followed by 2 days of intravenous pelareorep. Laboratory studies and imaging were acquired upon recruitment and periodically thereafter. Results: Six patients participated, including three glioblastoma, two diffuse intrinsic pontine glioma, and one medulloblastoma. Two pelareorep dose levels of 3 × 10 Conclusions: Sargramostim/pelareorep was administered to pediatric patients with recurrent or refractory high-grade brain tumors. Hyponatremia was the only dose limiting toxicity (DLT), though maximum tolerated dose (MTD) was not determined.

Indexed as

oncolytic virotherapypediatric brain tumorsreovirussargramostim

Identifiers

PMID35821679
PMCPMC9268737
OpenAlexW4283020820

What OpenQuestion holds

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LicenceCC BY-NC
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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.