Evidence map›Paper›PMID 19840379›Full record

Trial reportBMC cancer2009

Early termination of ISRCTN45828668, a phase 1/2 prospective, randomized study of sulfasalazine for the treatment of progressing malignant gliomas in adults.

Pierre A Robe, Didier H Martin, Minh T Nguyen-Khac, Maria Artesi, Manuel Deprez, Adelin Albert, Sophie Vanbelle, Stephane Califice, Markus Bredel, Vincent Bours

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in BMC 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 NCT04205357 (Phase I Trial Combining Sulfasalazine and Gamma Knife Radiosurgery for Recurrent Glioblastoma), which is not on this map. Cited by 112 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
112citing papers in PubMed, 1 pooled it
3.0field-weighted citation impact, top 9% 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.

NCT04205357 phase1completednot on this mapstarted 2020, after this paper: background citation

Phase I Trial Combining Sulfasalazine and Gamma Knife Radiosurgery for Recurrent Glioblastoma

TypeinterventionalSponsorHaukeland University HospitalRan2020 to 2022Enrolled24ConditionsGlioma, Glioblastoma, Recurrent GlioblastomaArmsSulfasalazine
3 · Its place in the literature

Who cites it

112 citing papers in PubMed, 1 synthesis or guideline pooled it, 179 citations in OpenAlex.

  1. Pooled it
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  19. Breaking Down Glioma-Microenvironment Crosstalk.The Neuroscientist : a review journal bringing neurobiology, neurology and psychiatry · 2025
    Review
  20. Review

52 more citing papers are in PubMed but not listed here.

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 3 institutions in 2 countries.

Pierre A RobeDepartment of Surgery (Neurosurgery), University of Liège, Domaine du Sart Tilman, B35, 4000 Liège, Belgium. p.robe@umcutrecht.nl
Didier H Martin
Minh T Nguyen-Khac
Maria Artesi
Manuel Deprez
Adelin Albert
Sophie Vanbelle
Stephane Califice
Markus Bredel
Vincent Bours
University of Liège · BENorthwestern University · USOncoMed (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSulfasalazine, a NF-kappaB and x(c)-cystine/glutamate antiport inhibitor, has demonstrated a strong antitumoral potential in preclinical models of malignant gliomas. As it presents an excellent safety profile, we initiated a phase 1/2 clinical study of this anti-inflammatory drug for the treatment of recurrent WHO grade 3 and 4 astrocytic gliomas in adults.

methods10 patients with advanced recurrent anaplastic astrocytoma (n = 2) or glioblastoma (n = 8) aged 32-62 years were recruited prior to the planned interim analysis of the study. Subjects were randomly assigned to daily doses of 1.5, 3, 4.5, or 6 grams of oral sulfasalazine, and treated until clinical or radiological evidence of disease progression or the development of serious or unbearable side effects. Primary endpoints were the evaluation of toxicities according to the CTCAE v.3.0, and the observation of radiological tumor responses based on MacDonald criteria.

resultsNo clinical response was observed. One tumor remained stable for 2 months with sulfasalazine treatment, at the lowest daily dose of the drug. The median progression-free survival was 32 days. Side effects were common, as all patients developed grade 1-3 adverse events (mean: 7.2/patient), four patients developed grade 4 toxicity. Two patients died while on treatment or shortly after its discontinuation.

conclusionAlthough the proper influence of sulfasalazine treatment on patient outcome was difficult to ascertain in these debilitated patients with a large tumor burden (median KPS = 50), ISRCTN45828668 was terminated after its interim analysis. This study urges to exert cautiousness in future trials of Sulfasalazine for the treatment of malignant gliomas.

trial registrationCurrent Controlled Trials ISRCTN45828668.

Indexed as

Early Termination of Clinical TrialsAdultDisease ProgressionFemaleGliomaHumansMaleMiddle AgedProspective StudiesSulfasalazineTreatment FailureSulfasalazine

Identifiers

PMID19840379
PMCPMC2771045
OpenAlexW2042890278

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.