Evidence map›Paper›PMID 32554977›Full record

ArticleJournal of immunotherapy (Hagerstown, Md. : 1997)2020

A Phase I, Dose Escalation, Single Dose Trial of Oral Attenuated Salmonella typhimurium Containing Human IL-2 in Patients With Metastatic Gastrointestinal Cancers.

Thomas J Gniadek, Lance Augustin, Janet Schottel, Arnold Leonard, Daniel Saltzman, Edward Greeno, Gerald Batist

Open access · hybridAbstract readClinical Trial, Phase I
In one paragraph

Article in Journal of immunotherapy (Hagerstown, Md. : 1997), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 54 papers.

0numbers the graph read from it
0cells of the map it votes in
54citing papers in PubMed
3.7field-weighted citation impact, top 6% 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.

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

54 citing papers in PubMed, 64 citations in OpenAlex.

  1. Trial
  2. Review
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  6. Review
  7. Article
  8. Review
  9. AttenuatedFrontiers in immunology · 2026
    Review
  10. Optimization Strategies and Synergistic Applications of EngineeredInternational journal of nanomedicine · 2026
    Review
  11. Biomedicines · 2025
    Review
  12. Review
  13. Review
  14. Review
  15. Review
  16. Review
  17. Review
  18. Review
  19. Article
  20. Designing live bacterial therapeutics for cancer.Advanced drug delivery reviews · 2025
    Review
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

7 authors at 4 institutions in 3 countries.

Thomas J GniadekDepartment of Pathology, Northshore University Health System, Evanston, IL.
Lance AugustinDepartments of Biochemistry, Molecular Biology and Biophysics.
Janet SchottelDepartments of Biochemistry, Molecular Biology and Biophysics.
Arnold LeonardSurgery, Division of Pediatric Surgery.
Daniel SaltzmanSurgery, Division of Pediatric Surgery.
Edward GreenoDepartment of Medicine, Division of Hematology and Oncology, University of Minnesota, Minneapolis/St. Paul.
Gerald BatistMcGill Centre for Translational Research in Cancer, Segal Cancer Centre, Jewish General Hospital, Montreal, QC, Canada.
Institute of Molecular Biology and Biophysics · RUJewish General Hospital · CANorthShore University HealthSystem · USUniversity of Minnesota · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Salmonella has been shown to preferentially colonize solid tumors. It is known that toxicity limits the systemic administration of immunomodulatory cytokines that have a significant anticancer effect. Therefore, we tested a unique cancer treatment strategy comprised of oral delivery of Saltikva, an attenuated strain of Salmonella typhimurium that contain the human gene for interleukin-2. In preclinical experimentation, a significant antitumor effect without toxicity was observed. A dose escalation, single dose, Phase I trial was conducted. Dose escalation (10 to 10) while monitoring for dose limiting toxicity and response was performed. Flow cytometry was conducted to determine the immunologic effect. In total 22 patients were administered Saltikva. Eight patients did not complete the trial. No toxicity or adverse events were observed. There was no survival advantage. Flow cytometry demonstrated an increase in circulating natural killer (NK) cells and NK-T cells when comparing the prestudy period. The results of this phase I dose escalation study show that oral attenuated S. typhimurium containing the human interleukin-2 gene caused no significant toxicities up to doses of 10 colony forming unit. There was no evidence of partial or complete response. All patients had progressive disease and eventually succumbed to their illness. Although no survival advantage was seen in this single dose study, the statistically significant increase in circulating NK and NK-T cell demonstrates an immunologic effect from this treatment regimen and suggest that a multiple dose study should be undertaken.

Indexed as

Biological TherapyBiomarkersCombined Modality TherapyDisease ManagementFemaleGastrointestinal NeoplasmsHumansImmunotherapyInterleukin-2LymphocytesMaleNeoplasm MetastasisNeoplasm StagingPalliative CarePractice Guidelines as TopicSalmonella typhimuriumBiomarkersIL2 protein, humanInterleukin-2

Identifiers

PMID32554977
PMCPMC7458080
OpenAlexW3036843612

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.