Evidence map›Paper›PMID 19640287›Full record

Trial reportJournal of translational medicine2009

Phase I/II open-label study of the biologic effects of the interleukin-2 immunocytokine EMD 273063 (hu14.18-IL2) in patients with metastatic malignant melanoma.

Antoni Ribas, John M Kirkwood, Michael B Atkins, Theresa L Whiteside, William Gooding, Andreas Kovar, Stephen D Gillies, Oscar Kashala, Michael A Morse

Open access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of translational medicine, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed
1.6field-weighted citation impact, top 17% 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

25 citing papers in PubMed, 42 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Article
  5. Article
  6. The present and future of immunocytokines for cancer treatment.Cellular and molecular life sciences : CMLS · 2022
    Review
  7. Review
  8. Utilizing Immunocytokines for Cancer Therapy.Antibodies (Basel, Switzerland) · 2021
    Review
  9. Review
  10. Review
  11. Article
  12. Review
  13. Review
  14. Review
  15. Review
  16. Article
  17. Article
  18. Article
  19. Immunocytokines: a review of molecules in clinical development for cancer therapy.Clinical pharmacology : advances and applications · 2013
    Article
  20. 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

9 authors at 8 institutions in 2 countries.

Antoni RibasUniversity of California, 11-934 Factor Building, UCLA Medical Center, Los Angeles, CA 90095-1782, USA. aribas@mednet.ucla.edu
John M Kirkwood
Michael B Atkins
Theresa L Whiteside
William Gooding
Andreas Kovar
Stephen D Gillies
Oscar Kashala
Michael A Morse
UPMC Hillman Cancer Center · USBeth Israel Deaconess Medical Center · USDuke University Hospital · USMerck (Germany) · DEOno Pharmaceutical (United States) · USscPharmaceuticals (United States) · USUCLA Medical Center · USUniversity of Pittsburgh Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo explore the biological activity of EMD 273063 (hu14.18-IL2), a humanized anti-GD2 monoclonal antibody fused to interleukin-2 (IL2), in patients with unresectable, stage IV cutaneous melanoma as measured by induction of immune activation at the tumor site and in peripheral blood.

methodsNine patients were treated with 4 mg/m2 per day of EMD 273063 given as a 4-h intravenous infusion on days 1, 2, and 3 every four weeks (one cycle). Peripheral blood was analyzed for T cell and natural killer cell phenotype and frequency, as well as levels of soluble IL2 receptor (sIL2R), IL10, IL6, tumor necrosis factor alpha and neopterin. Biopsies of tumor metastasis were performed prior to therapy and at day 10 of the first 2 cycles to study lymphocyte accumulation by immunohistochemistry.

resultsTreatment was generally well tolerated and there were no study drug-related grade 4 adverse events. Grade 3 events were mainly those associated with IL2, most commonly rigors (3 patients) and pyrexia (2 patients). Best response on therapy was stable disease in 2 patients. There were no objective tumor regressions by standard response criteria. Systemic immune activation was demonstrated by increases in serum levels of sIL2R, IL10, and neopterin. There was evidence of increased tumor infiltration by T cells, but not NK cells, in most post-dosing biopsies, suggesting recruitment of immune cells to the tumor site.

conclusionEMD 273063 demonstrated biologic activity with increased immune-related cytokines and intratumoral changes in some patients consistent with the suspected mechanism of action of this immunocytokine.

Indexed as

AdultAgedAntibodies, MonoclonalArea Under CurveBiopsyCytokinesFemaleFollow-Up StudiesHalf-LifeHumansImmunohistochemistryInterleukin-2MaleMelanomaMetabolic Clearance RateMiddle AgedAntibodies, MonoclonalCytokinesInterleukin-2lorukafusp alfa

Identifiers

PMID19640287
PMCPMC2724499
OpenAlexW2139837928

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.