Evidence map›Paper›PMID 19127265›Full record

Trial reportBritish journal of cancer2009

A phase I-II study of the histone deacetylase inhibitor valproic acid plus chemoimmunotherapy in patients with advanced melanoma.

A Rocca, S Minucci, G Tosti, D Croci, F Contegno, M Ballarini, F Nolè, E Munzone, A Salmaggi, A Goldhirsch and 2 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in British journal of cancer, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05920512 (PLA General Hospital), which is not on this map. Cited by 32 papers.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed
4.2field-weighted citation impact, top 5% 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.

NCT05920512 phase1 / phase2unknown statusnot on this mapstarted 2022, after this paper: background citation

PLA General Hospital

TypeinterventionalSponsorXue-chun LuRan2022 to 2025Enrolled10ConditionsHemophiliaArmsSodium valproate extended-release tablets
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 79 citations in OpenAlex.

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  4. A comprehensive review on pharmacological applications and drug-induced toxicity of valproic acid.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2023
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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

12 authors at 4 institutions in 1 country.

A RoccaDepartment of Medicine, European Institute of Oncology, Via Ripamonti 435, Milan 20141, Italy. a.rocca@irst.emr.it
S Minucci
G Tosti
D Croci
F Contegno
M Ballarini
F Nolè
E Munzone
A Salmaggi
A Goldhirsch
P G Pelicci
A Testori
European Institute of Oncology · ITRipamonti · ITFondazione IRCCS Istituto Neurologico Carlo Besta · ITUniversity of Milan · IT

Funding

TRANSLOCATION OF p66Shc: KINETICS, FUNCTION, APOPTOSISP01AG025532 · NIA · UNIVERSITY OF CALIFORNIA AT DAVIS · PI KIM, KYOUNGMI · 2007 to 2017
$12.1M
NIA NIH HHS P01 AG025532
6 · The paper itself

Abstract

We explored in a phase I/II clinical trial the combination of valproic acid (VPA), a clinically available histone deacetylase inhibitor, with standard chemoimmunotherapy in patients with advanced melanoma, to evaluate its clinical activity, to correlate the clinical response with the biological activity of VPA and to assess toxicity. Patients were treated initially with VPA alone for 6 weeks. The inhibition of the target in non-tumour peripheral blood cells (taken as a potential surrogate marker) was measured periodically, and valproate dosing adjusted with the attempt to reach a measurable inhibition. After the treatment with valproate alone, dacarbazine plus interferon-alpha was started in combination with valproate. Twenty-nine eligible patients started taking valproate and 18 received chemoimmunotherapy and are assessable for response. We observed one complete response, two partial remissions and three disease stabilisations lasting longer than 24 weeks. With the higher valproate dosages needed to reach a measurable inhibition of the target, we observed an increase of side effects in those patients who received chemoimmunotherapy. The combination of VPA and chemoimmunotherapy did not produce results overtly superior to standard therapy in patients with advanced melanoma and toxicity was not negligible, casting some doubts on the clinical use of VPA in this setting (at least in the administration schedule adopted).

Indexed as

Histone Deacetylase InhibitorsAdultAgedDacarbazineEnzyme InhibitorsFemaleHumansInterferon-alphaMaleMelanomaMiddle AgedValproic AcidDacarbazineEnzyme InhibitorsHistone Deacetylase InhibitorsInterferon-alphaValproic Acid

Identifiers

PMID19127265
PMCPMC2634690
OpenAlexW2044389296

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.