Evidence map›Paper›PMID 38955178›Full record

ArticleCell reports. Medicine2024

A multicenter, phase 1, Adult Brain Tumor Consortium trial of oral terameprocol for patients with recurrent high-grade glioma (GATOR).

Manmeet S Ahluwalia, Ahmad Ozair, Michelle Rudek, Xiaobu Ye, Matthias Holdhoff, Frank S Lieberman, Anna F Piotrowski, Burt Nabors, Arati Desai, Glenn Lesser and 6 more

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Cell reports. Medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02575794 (Phase 1 Dose Escalation and Drug Distribution Study of Oral Terameprocol in Patients With Recurrent High Grade Glioma), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

NCT02575794 phase1completednot on this map

Phase 1 Dose Escalation and Drug Distribution Study of Oral Terameprocol in Patients With Recurrent High Grade Glioma

TypeinterventionalSponsorSidney Kimmel Comprehensive Cancer Center at Johns HopkinsRan2018 to 2023Enrolled20ConditionsHigh Grade Glioma (III or IV)ArmsTerameprocol, Pharmacological Study
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
  4. Review
  5. 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

16 authors.

Manmeet S AhluwaliaRose and Ella Burkhardt Brain Tumor and Neuro-Oncology Center, Cleveland Clinic, Cleveland, OH, USA; Miami Cancer Institute, Baptist Health South Florida, Miami, FL, USA. Electronic address: manmeeta@baptisthealth.net.
Ahmad OzairMiami Cancer Institute, Baptist Health South Florida, Miami, FL, USA; Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.
Michelle RudekSidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Xiaobu YeSidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Johns Hopkins University School of Medicine, Baltimore, MD, USA; Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Matthias HoldhoffSidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Frank S LiebermanDepartment of Neurology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Anna F PiotrowskiDepartment of Neuro-Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Burt NaborsDepartment of Neurology, Heersink School of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.
Arati DesaiDepartment of Neurology, Heersink School of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.
Glenn LesserDepartment of Hematology and Oncology, Wake Forest Medical Center, Winston, NC, USA.
Ru Chih HuangKrieger School of Arts and Sciences, Johns Hopkins University, Baltimore, MD, USA.
Steve GlennIndependent Consultant to Erimos Pharmaceuticals, Houston, TX, USA.
Atulya A KhoslaMiami Cancer Institute, Baptist Health South Florida, Miami, FL, USA.
David M PeereboomRose and Ella Burkhardt Brain Tumor and Neuro-Oncology Center, Cleveland Clinic, Cleveland, OH, USA.
Patrick Y WenDepartment of Neurology, Harvard Medical School, Boston, MA, USA; Center for Neuro-Oncology, Dana Farber Cancer Institute, Boston, MA, USA.
Stuart A GrossmanSidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Johns Hopkins University School of Medicine, Baltimore, MD, USA.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
Translational Research Central ServicesP30CA006973 · NCI · JOHNS HOPKINS UNIVERSITY · PI WILLIAM George NELSON · 1985 to 2026
$208.6M
QAQC Johns Hopkins Institute for Clinical and Translational ResearchUL1TR003098 · NCATS · JOHNS HOPKINS UNIVERSITY · PI FORD, DANIEL ERNEST · 2019 to 2023
$57.7M
Adult Brain Tumor Consortium (ABTC)UM1CA137443 · NCI · JOHNS HOPKINS UNIVERSITY · PI GROSSMAN, STUART A · 2014 to 2020
$9.7M
UPLC with Tandem MS for Sensitive Quantitative Analysis of Small MoleculesS10RR026824 · NCRR · JOHNS HOPKINS UNIVERSITY · PI RUDEK, MICHELLE A · 2010 to 2010
$429k
Acquisition of a triple quadrupole mass spectrometer for small molecule analysisS10OD020091 · OD · JOHNS HOPKINS UNIVERSITY · PI RUDEK, MICHELLE A · 2015 to 2015
$314k
NCATS NIH HHS UL1 TR003098NCI NIH HHS P30 CA006973NCI NIH HHS P30 CA008748NCI NIH HHS UM1 CA137443NCRR NIH HHS S10 RR026824NIH HHS S10 OD020091
6 · The paper itself

Abstract

Recurrent high-grade gliomas (rHGGs) have a dismal prognosis, where the maximum tolerated dose (MTD) of IV terameprocol (5 days/month), a transcriptional inhibitor of specificity protein 1 (Sp1)-regulated proteins, is 1,700 mg/day with median area under the plasma concentration-time curve (AUC) of 31.3 μg∗h/mL. Given potentially increased efficacy with sustained systemic exposure and challenging logistics of daily IV therapy, here we investigate oral terameprocol for rHGGs in a multicenter, phase 1 trial (GATOR). Using a 3 + 3 dose-escalation design, we enroll 20 patients, with median age 60 years (range 31-80), 70% male, and median one relapse (range 1-3). Fasting patients tolerate 1,200 mg/day (n = 3), 2,400 mg/day (n = 6), 3,600 mg/day (n = 3), and 6,000 mg/day (n = 2) oral doses without major toxicities. However, increased dosage does not lead to increased systemic exposure, including in fed state (6,000 mg/day, n = 4), with maximal AUC <5 μg∗h/mL. These findings warrant trials investigating approaches that provide sustained systemic levels of transcription inhibitors to exploit their therapeutic potential. This study was registered at ClinicalTrials.gov (NCT02575794).

Indexed as

Brain NeoplasmsGliomaAdministration, OralAdultAgedAged, 80 and overFemaleHumansMaleMaximum Tolerated DoseMiddle AgedNeoplasm GradingNeoplasm Recurrence, Localastrocytoma (MeSH)brain malignancybrain tumorCNS cancerEM-1421glioblastomaglioma (MeSH)NDGASp1 transcription factortetra-o-methyl nordihydroguaiaretic acid

Identifiers

PMID38955178
PMCPMC11293336

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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.