Evidence map›Paper›PMID 28319448›Full record

ArticleHuman gene therapy. Clinical development2017

Rationale and Design of a Phase 1 Clinical Trial to Evaluate HSV G207 Alone or with a Single Radiation Dose in Children with Progressive or Recurrent Malignant Supratentorial Brain Tumors.

Alicia M Waters, James M Johnston, Alyssa T Reddy, John Fiveash, Avi Madan-Swain, Kara Kachurak, Asim K Bag, G Yancey Gillespie, James M Markert, Gregory K Friedman

Abstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Human gene therapy. Clinical development, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed
6.2field-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

39 citing papers in PubMed, 57 citations in OpenAlex.

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  13. Biological Therapies in the Treatment of Cancer-Update and New Directions.International journal of molecular sciences · 2021
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  17. Clinical CAR-T Cell and Oncolytic Virotherapy for Cancer Treatment.Molecular therapy : the journal of the American Society of Gene Therapy · 2021
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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 2 institutions in 1 country.

Alicia M Waters1 Department of Surgery, Division of Pediatric Surgery, University of Alabama at Birmingham , Birmingham, Alabama.
James M Johnston2 Department of Neurosurgery, University of Alabama at Birmingham , Birmingham, Alabama.
Alyssa T Reddy3 Department of Pediatrics, Division of Hematology/Oncology, University of Alabama at Birmingham , Birmingham, Alabama.
John Fiveash4 Department of Radiation Oncology, University of Alabama at Birmingham , Birmingham, Alabama.
Avi Madan-Swain3 Department of Pediatrics, Division of Hematology/Oncology, University of Alabama at Birmingham , Birmingham, Alabama.
Kara Kachurak5 Division of Hematology/Oncology, Children's of Alabama , Birmingham, Alabama.
Asim K Bag6 Department of Radiology, University of Alabama at Birmingham , Birmingham, Alabama.
G Yancey Gillespie2 Department of Neurosurgery, University of Alabama at Birmingham , Birmingham, Alabama.
James M Markert2 Department of Neurosurgery, University of Alabama at Birmingham , Birmingham, Alabama.
Gregory K Friedman3 Department of Pediatrics, Division of Hematology/Oncology, University of Alabama at Birmingham , Birmingham, Alabama.
University of Alabama at Birmingham · USChildren's of Alabama · US

Funding

Virus Production CoreP01CA071933 · NCI · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI WEICHSELBAUM, RALPH R · 1997 to 2013
$14.5M
CONTEMPORARY THERAPEUTICS FOR ANAPLASTIC GLIOMASP20CA151129 · NCI · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI GILLESPIE, G. YANCEY · 2011 to 2013
$2.3M
Ph1 of HSV G207 and Radiation to Treat Pediatric Brain Tumors IND16294 (12/10/14)R01FD005379 · FDA · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI FRIEDMAN, GREGORY K · 2016 to 2018
$750k
FDA HHS R01 FD005379NCI NIH HHS P01 CA071933NCI NIH HHS P20 CA151129
6 · The paper itself

Abstract

Primary central nervous system tumors are the most common solid neoplasm of childhood and the leading cause of cancer-related death in pediatric patients. Survival rates for children with malignant supratentorial brain tumors are poor despite aggressive treatment with combinations of surgery, radiation, and chemotherapy, and survivors often suffer from damaging lifelong sequelae from current therapies. Novel innovative treatments are greatly needed. One promising new approach is the use of a genetically engineered, conditionally replicating herpes simplex virus (HSV) that has shown tumor-specific tropism and potential efficacy in the treatment of malignant brain tumors. G207 is a genetically engineered HSV-1 lacking genes essential for replication in normal brain cells. Safety has been established in preclinical investigations involving intracranial inoculation in the highly HSV-sensitive owl monkey (Aotus nancymai), and in three adult phase 1 trials in recurrent/progressive high-grade gliomas. No dose-limiting toxicities were seen in the adult studies and a maximum tolerated dose was not reached. Approximately half of the 35 treated adults had radiographic or neuropathologic evidence of response at a minimum of one time point. Preclinical studies in pediatric brain tumor models indicate that a variety of pediatric tumor types are highly sensitive to killing by G207. This clinical protocol outlines a first in human children study of intratumoral inoculation of an oncolytic virus via catheters placed directly into recurrent or progressive supratentorial malignant tumors.

Indexed as

Oncolytic VirotherapyResearch DesignAdolescentAdultBrain NeoplasmsChildChild, PreschoolFemaleGenetic TherapyGenetic VectorsHerpesvirus 1, HumanHumansMaleNeoplasm Recurrence, LocalOncolytic VirusesSafetybrain tumorsG207HSVoncolyticpediatricvirotherapy

Identifiers

PMID28319448
PMCPMC5369388
OpenAlexW2590453754

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.