Evidence map›Paper›PMID 38712133›Full record

ArticlemedRxiv : the preprint server for health sciences2024

Phase 2 Study of Sorafenib, Valproic Acid, and Sildenafil in the Treatment of Recurrent High-Grade Glioma.

Andrew S Poklepovic, Palak Shah, Mary Beth Tombes, Ellen Shrader, Dipankar Bandyopadhyay, Xiaoyan Deng, Catherine H Roberts, Alison A Ryan, Daniel Hudson, Heidi Sankala and 3 more

Registry-linked trialAbstract readPreprint
PubMed Full text at PMC Publisher
In one paragraph

Article in medRxiv : the preprint server for health sciences, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01817751 (Phase 2 Study of Sorafenib, Valproic Acid, and Sildenafil in the Treatment of Recurrent High-Grade Glioma), which is not on this map. Not yet cited in PubMed.

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

NCT01817751 phase2completednot on this map

Phase 2 Study of Sorafenib, Valproic Acid, and Sildenafil in the Treatment of Recurrent High-Grade Glioma

TypeinterventionalSponsorVirginia Commonwealth UniversityRan2013 to 2023Enrolled47ConditionsGlioblastoma, Recurrent Adult Brain Neoplasm, Malignant Glioma, WHO Grade III GliomaArmssorafenib tosylate, valproic acid, sildenafil citrate
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

13 authors.

Andrew S PoklepovicDepartment of Internal Medicine, Virginia Commonwealth University, Richmond, Virginia. USA.
Palak ShahDepartment of Internal Medicine, Virginia Commonwealth University, Richmond, Virginia. USA.
Mary Beth TombesDepartment of Massey Cancer Center, Virginia Commonwealth University, Richmond, Virginia. USA.
Ellen ShraderDepartment of Massey Cancer Center, Virginia Commonwealth University, Richmond, Virginia. USA.
Dipankar BandyopadhyayDepartment of Biostatistics, Virginia Commonwealth University, Richmond, Virginia. USA.
Xiaoyan DengDepartment of Biostatistics, Virginia Commonwealth University, Richmond, Virginia. USA.
Catherine H RobertsDepartment of Massey Cancer Center, Virginia Commonwealth University, Richmond, Virginia. USA.
Alison A RyanDepartment of Massey Cancer Center, Virginia Commonwealth University, Richmond, Virginia. USA.
Daniel HudsonDepartment of Massey Cancer Center, Virginia Commonwealth University, Richmond, Virginia. USA.
Heidi SankalaDepartment of Massey Cancer Center, Virginia Commonwealth University, Richmond, Virginia. USA.
Maciej KmieciakDepartment of Internal Medicine, Virginia Commonwealth University, Richmond, Virginia. USA.
Paul DentDepartment of Internal Medicine, Virginia Commonwealth University, Richmond, Virginia. USA.
Mark G MalkinDepartment of Neurology, Virginia Commonwealth University, Richmond, Virginia. USA.

Funding

Virus Vector Shared ResourceP30CA016059 · NCI · VIRGINIA COMMONWEALTH UNIVERSITY · PI Kim Felder Rhoads · 1985 to 2026
$51.0M
NCI NIH HHS P30 CA016059
6 · The paper itself

Abstract

Here we report the results of a single-center phase 2 clinical trial combining sorafenib tosylate, valproic acid, and sildenafil for the treatment of patients with recurrent high-grade glioma (NCT01817751). Clinical toxicities were grade 1 and grade 2, with one grade 3 toxicity for maculopapular rash (6.4%). For all evaluable patients, the median progression-free survival was 3.65 months and overall survival (OS) 10.0 months. There was promising evidence showing clinical activity and benefit. In the 33 evaluable patients, low protein levels of the chaperone GRP78 (HSPA5) was significantly associated with a better OS (p < 0.0026). A correlation between the expression of PDGFRα and OS approached significance (p < 0.0728). Five patients presently have a mean OS of 73.6 months and remain alive. This is the first therapeutic intervention glioblastoma trial to significantly associate GRP78 expression to OS. Our data suggest that the combination of sorafenib tosylate, valproic acid, and sildenafil requires additional clinical development in the recurrent glioma population.

Indexed as

Clinical trialgliomaGRP78PDGFRαsildenafilsorafenibvalproic acid

Identifiers

PMID38712133
PMCPMC11071549

What OpenQuestion holds

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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.