Evidence map›Paper›PMID 24586226›Full record

Trial reportPloS one2014

TG1042 (Adenovirus-interferon-γ) in primary cutaneous B-cell lymphomas: a phase II clinical trial.

Brigitte Dreno, Mirjana Urosevic-Maiwald, Youn Kim, Joan Guitart, Madeleine Duvic, Olivier Dereure, Amir Khammari, Anne-Chantal Knol, Anna Derbij, Monika Lusky and 8 more

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing 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

15 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
  4. Article
  5. Review
  6. Article
  7. Review
  8. Review
  9. Review
  10. Review
  11. The Interferon-Gamma Paradox in Cancer.Journal of interferon & cytokine research : the official journal of the International Society for Interferon and Cytokine Research · 2019
    Review
  12. The Dark Side of IFN-γ: Its Role in Promoting Cancer Immunoevasion.International journal of molecular sciences · 2017
    Review
  13. Review
  14. Review
  15. 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

18 authors.

Brigitte DrenoDepartment of Skin Cancer, University Hospital, Nantes, France.
Mirjana Urosevic-MaiwaldDepartment of Dermatology, University Hospital, Zurich, Switzerland.
Youn KimStanford University School of Medicine, Stanford, California, United States of America.
Joan GuitartNorthwestern University Medical School, Chicago, Illinois, United States of America.
Madeleine DuvicUniversity of Texas, M.D. Anderson Cancer Center, Houston, Texas, United States of America.
Olivier DereureDepartment of Dermatology, Saint Eloi Hospital, Montpellier, France.
Amir KhammariDepartment of Skin Cancer, University Hospital, Nantes, France.
Anne-Chantal KnolDepartment of Skin Cancer, University Hospital, Nantes, France.
Anna DerbijTransgene, Illkirch (Strasbourg), France.
Monika LuskyTransgene, Illkirch (Strasbourg), France.
Isabelle DidillonTransgene, Illkirch (Strasbourg), France.
Anne-Marie SantoniTransgene, Illkirch (Strasbourg), France.
Bruce AcresTransgene, Illkirch (Strasbourg), France.
Vincent BatailleTransgene, Illkirch (Strasbourg), France.
Marie-Pierre ChenardDepartment of Pathology, University Hospital, Strasbourg, France.
Pascal BleuzenTransgene, Illkirch (Strasbourg), France.
Jean-Marc LimacherTransgene, Illkirch (Strasbourg), France.
Reinhard DummerDepartment of Dermatology, University Hospital, Zurich, Switzerland.

Funding

Center for Clinical and Translational Sciences (CCTS)UL1TR000371 · NCATS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI MCPHERSON, DAVID D · 2012 to 2016
$13.4M
NCATS NIH HHS UL1 TR000371
6 · The paper itself

Abstract

rationalWhile a variety of registered therapies exist for Cutaneous T Cell Lymphoma, no such therapy is available for Cutaneous B Cell Therapy. In this context we performed a phase II, open label, multicenter, non-comparative study to evaluate the efficacy and safety of repeated intra-lesional administrations of TG1042 (adenovirus-interferon-γ) in patients with relapsing primary cutaneous B-cell lymphomas (CBCL).

methodThirteen patients have been enrolled and received intralesional injections of TG1042 containing 5×10(10) viral particles into up to six lesions simultaneously. Injections were performed on days 1, 8 and 15 of each of four consecutive 28 day cycles.

resultsEleven (85%) out of 13 enrolled patients showed an objective response after injections of TG1042. Seven patients (54%) exhibited complete and four (31%) displayed partial response. The median time to disease progression in the study population was 23.5 months (range 6.25 to 26+). Most commonly observed adverse events were minor to moderate flu-like symptoms, fatigue and injection site reactions.

conclusionsOur study showed that treatment with TG1042 was associated with a clinical benefit in the majority of the patients with relapsing CBCL, including tumor regression, a clinically meaningful duration of response and a good treatment tolerance.

trial registrationwww.clinicaltrials.govNCT00394693.

Indexed as

AdenoviridaeAdultAgedAged, 80 and overDisease ProgressionFemaleHumansInjections, IntralesionalInterferon-gammaLymphoma, T-Cell, CutaneousMaleMiddle AgedSkin NeoplasmsInterferon-gamma

Identifiers

PMID24586226
PMCPMC3933342

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.