Evidence map›Paper›PMID 40150841›Full record

Trial reportCancer science2025

A Multicenter Phase II Trial of Nimustine Hydrochloride Administered via Convection-Enhanced Delivery in Children With DIPG.

Ryuta Saito, Masayuki Kanamori, Yoshiki Arakawa, Yohei Mineharu, Yasuo Aihara, Kentaro Chiba, Toshihiro Kumabe, Ichiyo Shibahara, Yukihiko Sonoda, Kenichiro Matsuda and 4 more

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cancer science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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

2 citing papers in PubMed.

  1. Article
  2. Article
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.

Ryuta SaitoDepartment of Neurosurgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.ORCID https://orcid.org/0000-0002-2484-1360
Masayuki KanamoriDepartment of Neurosurgery, Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan.
Yoshiki ArakawaDepartment of Neurosurgery, Kyoto University Graduate School of Medicine, Sakyo-ku, Kyoto, Japan.ORCID https://orcid.org/0000-0003-4626-4645
Yohei MineharuDepartment of Neurosurgery, Kyoto University Graduate School of Medicine, Sakyo-ku, Kyoto, Japan.
Yasuo AiharaDepartment of Neurosurgery, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan.
Kentaro ChibaDepartment of Neurosurgery, Tokyo Women's Medical University, Tokyo, Japan.
Toshihiro KumabeDepartment of Neurosurgery, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan.
Ichiyo ShibaharaDepartment of Neurosurgery, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan.
Yukihiko SonodaDepartment of Neurosurgery, Yamagata University, Yamagata, Japan.
Kenichiro MatsudaDepartment of Neurosurgery, Yamagata University, Yamagata, Japan.
Manabu KinoshitaDepartment of Neurosurgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Aya SatoDepartment of Neurosurgery, Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan.
Fumiaki TakahashiDepartment of Information Science, Iwate Medical University, Iwate, Japan.
Teiji TominagaDepartment of Neurosurgery, Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan.

Funding

Japan Agency for Medical Research and Development (AMED) JP18lk0201070Japan Agency for Medical Research and Development (AMED) JP21lm0203119Japan Agency for Medical Research and Development (AMED) JP24ck0106903
6 · The paper itself

Abstract

Diffuse intrinsic pontine glioma (DIPG) is a very challenging-to-treat pediatric malignant tumor, with a median survival time of < 12 months. Convection-enhanced delivery (CED) allows for direct drug administration into the tumor site, showing potential as a novel therapeutic approach. This study evaluated the efficacy of CED of nimustine hydrochloride (ACNU) in children with DIPG. This phase 2, single-arm, multicenter study enrolled patients aged 3-21 years and diagnosed with DIPG. The investigational treatment commenced 1 month after completing radiotherapy (local 50-60 Gy). The treatment involved stereotactic brain surgery for catheter placement, followed by ACNU administration via a CED catheter at a concentration of 0.75 mg/mL for 2-3 days until a cumulative dose of 7 (±0.3) mL was achieved. The primary endpoint was the 1-year survival rate. From April 2018 to March 2020, 21 children were enrolled in the trial and treated, with 20 evaluable for the primary endpoint. The 1-year survival rate from the start of radiotherapy was 60%, and the median survival time was 15 months. The response rate was analyzed in 20 patients, with one complete response (CR), six partial responses (PR), nine stable diseases, and four progressive diseases, resulting in a response rate of 35% (CR + PR). The CED of ACNU in the brainstem of children with DIPG after radiotherapy appears to be an effective therapeutic strategy. This approach warrants further development as a treatment for children with DIPG. This study is registered with jRCT (No. jRCT2021190003).

Indexed as

Antineoplastic AgentsBrain Stem NeoplasmsDiffuse Intrinsic Pontine GliomaNimustineAdolescentChildChild, PreschoolConvectionDrug Delivery SystemsFemaleHumansMaleSurvival RateTreatment OutcomeYoung AdultAntineoplastic AgentsNimustineconvection‐enhanced deliverydiffuse intrinsic pontine gliomalocal chemotherapynimustine hydrochloridephase II investigator‐initiated clinical trial

Identifiers

PMID40150841
PMCPMC12127113

What OpenQuestion holds

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Registered trials

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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.