Evidence map›Paper›PMID 22057678›Full record

Trial reportCancer immunology, immunotherapy : CII2012

Increased lymphocyte infiltration in patients with head and neck cancer treated with the IRX-2 immunotherapy regimen.

Neil L Berinstein, Gregory T Wolf, Paul H Naylor, Lorraine Baltzer, James E Egan, Harvey J Brandwein, Theresa L Whiteside, Lynn C Goldstein, Adel El-Naggar, Cecile Badoual and 3 more

2 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cancer immunology, immunotherapy : CII, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed
1.4field-weighted citation impact, top 18% 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.

NCT00210470 phase2completednot on this map

A Phase 2, Open-label Trial of the Safety and Biological Effect of Subcutaneous IRX-2 (With Cyclophosphamide, Indomethacin, and Zinc) in Patients With Resectable Cancer of the Head and Neck

TypeinterventionalSponsorBrooklyn ImmunoTherapeutics, LLCRan2005 to 2012Enrolled27ConditionsSquamous Cell Carcinoma of the Head and NeckArmsIRX-2, Cyclophosphamide, Indomethacin, Zinc, Omeprazole
NCT02609386 phase2completednot on this mapstarted 2016, after this paper: background citation

A Randomized Phase 2 Trial of Neoadjuvant and Adjuvant Therapy With the IRX 2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity

TypeinterventionalSponsorBrooklyn ImmunoTherapeutics, LLCRan2016 to 2022Enrolled105ConditionsSquamous Cell Carcinoma of the Oral CavityArmsIRX-2, Cyclophosphamide, Indomethacin, Zinc-containing multivitamin, Omeprazole
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 43 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. Review
  6. Article
  7. Article
  8. Review
  9. Review
  10. Therapeutic vaccines for high-risk HPV-associated diseases.Papillomavirus research (Amsterdam, Netherlands) · 2018
    Review
  11. Review
  12. Review
  13. Article
  14. Prognostic value of CD45 transcriptional expression in head and neck cancer.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2018
    Article
  15. Head and Neck Carcinoma Immunotherapy: Facts and Hopes.Clinical cancer research : an official journal of the American Association for Cancer Research · 2018
    Review
  16. Review
  17. Article
  18. Article
  19. Immunostimulatory Activity of the Cytokine-Based Biologic, IRX-2, on Human Papillomavirus-Exposed Langerhans Cells.Journal of interferon & cytokine research : the official journal of the International Society for Interferon and Cytokine Research · 2016
    Article
  20. 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

13 authors at 5 institutions in 2 countries.

Neil L BerinsteinIRX Therapeutics Inc., New York, NY, USA.
Gregory T Wolf
Paul H Naylor
Lorraine Baltzer
James E Egan
Harvey J Brandwein
Theresa L Whiteside
Lynn C Goldstein
Adel El-Naggar
Cecile Badoual
Wolf-Herve Fridman
J Michael White
John W Hadden
Hôpital Européen · FRDMH Associates (United States) · USThe University of Texas MD Anderson Cancer Center · USUniversity of Michigan–Ann Arbor · USUPMC Hillman Cancer Center · US

Funding

A Study of the Function of Hormones Present in Taste BudsZIAAG000962 · NIA · NATIONAL INSTITUTE ON AGING · PI CHIA, CHEE W · 2009 to 2022
$3.5M
A Study of the Function of Hormones Present in Taste BudsZ01AG000962 · NIA · NATIONAL INSTITUTE ON AGING · PI EGAN, JOSEPHINE · 2006 to 2008
$609k
Intramural NIH HHS Z01 AG000962
6 · The paper itself

Abstract

Twenty-seven subjects with squamous cell cancer of the head and neck received the neoadjuvant IRX-2 immunotherapy regimen prior to surgery in a Phase 2 trial. Pretreatment tumor biopsies were compared with the primary tumor surgical specimens for lymphocyte infiltration, necrosis and fibrosis, using hematoxylin and eosin stain and immunohistochemistry in 25 subjects. Sections were examined by three pathologists. Relative to pretreatment biopsies, increases in lymphocyte infiltration (LI) were seen using H and E or immunohistochemistry. CD3+ CD4+ T cells and CD20+ B cells were primarily found in the peritumoral stroma and CD3+ CD8+ T cells and CD68+ macrophages were mainly intratumoral. LI in the surgical specimens were associated with reductions in the primary tumor size. Improved survival at 5 years was correlated with high overall LI in the tumor specimens. Neoadjuvant IRX-2 immunotherapy regimen may restore immune responsiveness presumably by mobilizing tumor infiltrating effector lymphocytes and macrophages into the tumor.

Indexed as

ImmunotherapyAdultAgedCytokinesFemaleHead and Neck NeoplasmsHumansLymphocytes, Tumor-InfiltratingMaleMiddle AgedRegression AnalysisSurvival AnalysisCytokinesIRX 2

Identifiers

PMID22057678
PMCPMC5300054
OpenAlexW2088202198

What OpenQuestion holds

Textmetadata
LicenceTDM
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.