Evidence map›Paper›PMID 24327292›Full record

ArticleCancer immunology, immunotherapy : CII2014

Phase I trial of a recombinant yeast-CEA vaccine (GI-6207) in adults with metastatic CEA-expressing carcinoma.

Marijo Bilusic, Christopher R Heery, Philip M Arlen, Myrna Rauckhorst, David Apelian, Kwong Y Tsang, Jo A Tucker, Caroline Jochems, Jeffrey Schlom, James L Gulley and 1 more

Abstract readClinical Trial, Phase I
In one paragraph

Article in Cancer immunology, immunotherapy : CII, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 55 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed, 1 pooled it
4.7field-weighted citation impact, top 5% 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

55 citing papers in PubMed, 1 synthesis or guideline pooled it, 102 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Targeting Carcinoembryonic Antigen with DNA Vaccination: On-Target Adverse Events Link with Immunologic and Clinical Outcomes.Clinical cancer research : an official journal of the American Association for Cancer Research · 2016
    Trial
  5. Review
  6. Review
  7. Review
  8. Review
  9. Review
  10. Article
  11. Review
  12. Review
  13. CD276 as a Candidate Target for Immunotherapy in Medullary Thyroid Cancer.International journal of molecular sciences · 2023
    Article
  14. Article
  15. Review
  16. A Brief Introduction to Current Cancer Gene Therapy.Methods in molecular biology (Clifton, N.J.) · 2022
    Article
  17. Article
  18. Review
  19. Review
  20. New Horizons: Emerging Therapies and Targets in Thyroid Cancer.The Journal of clinical endocrinology and metabolism · 2021
    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

11 authors at 4 institutions in 1 country.

Marijo BilusicMedical Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Christopher R Heery
Philip M Arlen
Myrna Rauckhorst
David Apelian
Kwong Y Tsang
Jo A Tucker
Caroline Jochems
Jeffrey Schlom
James L Gulley
Ravi A Madan
Center for Cancer Research · USNational Cancer Institute · USNational Institutes of Health · USGlobeImmune (United States) · US

Funding

Cancer Therapy Clinical Trials Using Novel Recombinant VaccinesZIABC010666 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI GULLEY, JAMES L. · 2009 to 2025
$22.4M
Human T Cell Responses to Tumor Antigens for Cancer Vaccine DevelopmentZIABC010598 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI SCHLOM, JEFFREY · 2009 to 2025
$19.3M
Identification of human tumor-associated antigensZIABC010972 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI TSANG, KWONG YOK · 2009 to 2016
$6.0M
Vaccine Clinical TrialsZ01BC010666 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI GULLEY, JAMES L. · 2005 to 2008
$1.7M
Intramural NIH HHS Z01 BC010666
6 · The paper itself

Abstract

Yeast-CEA (GI-6207) is a therapeutic cancer vaccine genetically modified to express recombinant carcinoembryonic antigen (CEA) protein, using heat-killed yeast (Saccharomyces cerevisiae) as a vector. In preclinical studies, yeast-CEA induced a strong immune response to CEA and antitumor responses. Patients received subcutaneous vaccines every 2 weeks for 3 months and then monthly. Patients were enrolled at 3 sequential dose levels: 4, 16, and 40 yeast units (10(7) yeast particles/unit). Eligible patients were required to have serum CEA > 5 ng/mL or > 20 % CEA(+) tumor block, ECOG PS 0-2, and no history of autoimmunity. Restaging scans were performed at 3 months and then bimonthly. Peripheral blood was collected for the analysis of immune response (e.g., by ELISPOT assay). Twenty-five patients with metastatic CEA-expressing carcinomas were enrolled. Median patient age was 52 (range 39-81). A total of 135 vaccines were administered. The vaccine was well tolerated, and the most common adverse event was grade 1/2 injection-site reaction. Five patients had stable disease beyond 3 months (range 3.5-18 months), and each had CEA stabilization while on-study. Some patients showed evidence post-vaccination of increases in antigen-specific CD8(+) T cells and CD4(+) T lymphocytes and decreases in regulatory T cells. Of note, a patient with medullary thyroid cancer had substantial T cell responses and a vigorous inflammatory reaction at sites of metastatic disease. Yeast-CEA vaccination had minimal toxicity and induced some antigen-specific T cell responses and CEA stabilization in a heterogeneous, heavily pre-treated patient population. Further studies are required to determine the clinical benefit of yeast-CEA vaccination.

Indexed as

AdenocarcinomaAdultAgedAged, 80 and overCancer VaccinesCarcinoembryonic AntigenCD4-Positive T-LymphocytesCD8-Positive T-LymphocytesCells, CulturedColonic NeoplasmsCytokinesEnzyme-Linked Immunospot AssayFemaleFollow-Up StudiesGenetic EngineeringGenetic VectorsCancer VaccinesCarcinoembryonic AntigenCytokinesVaccines, DNAyeast-CEA vaccine

Identifiers

PMID24327292
PMCPMC3944709
OpenAlexW2022660421

What OpenQuestion holds

Textmetadata
LicenceTDM
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.