Evidence map›Paper›PMID 21871012›Full record

Trial reportExpert opinion on biological therapy2011

A pilot safety trial investigating a vector-based vaccine targeting carcinoembryonic antigen in combination with radiotherapy in patients with gastrointestinal malignancies metastatic to the liver.

James L Gulley, Ravi A Madan, Kwong-Yok Tsang, Philip M Arlen, Kevin Camphausen, Mahsa Mohebtash, Mitchell Kamrava, Jeffrey Schlom, Deborah Citrin

Open access · greenAbstract readClinical Trial
In one paragraph

Trial report in Expert opinion on biological therapy, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
1.3field-weighted citation impact, top 19% 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

18 citing papers in PubMed, 26 citations in OpenAlex.

  1. Review
  2. Review
  3. CEA vaccines.Human vaccines & immunotherapeutics · 2023
    Review
  4. Review
  5. Article
  6. Article
  7. Review
  8. Article
  9. Article
  10. Review
  11. Review
  12. Review
  13. Article
  14. Article
  15. Article
  16. Review
  17. Poxviral vectors for cancer immunotherapy.Expert opinion on biological therapy · 2012
    Review
  18. 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 4 institutions in 1 country.

James L GulleyNational Cancer Institute, National Institutes of Health, Center for Cancer Research, Laboratory of Tumor Immunology and Biology, 10 Center Dr, 8B09 MSC 1750, Bethesda, MD 20892, USA. gulleyj@mail.nih.gov
Ravi A Madan
Kwong-Yok Tsang
Philip M Arlen
Kevin Camphausen
Mahsa Mohebtash
Mitchell Kamrava
Jeffrey Schlom
Deborah Citrin
National Cancer Institute · USCenter for Cancer Research · USNational Institutes of Health · USWeatherford College · US

Funding

Strategies for Therapeutic Cancer Vaccine Clinical TrialsZIABC010425 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI SCHLOM, JEFFREY · 2009 to 2023
$13.7M
Clinical trials employing cancer vaccine combination therapiesZIABC010945 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI GULLEY, JAMES L. · 2009 to 2022
$9.6M
Clinical trials employing cancer vaccine combination therapiesZ01BC010945 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI GULLEY, JAMES L. · 2008 to 2008
$517k
Combination therapies involving novel cancer vaccinesZIABC011281 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI MADAN, RAVI · 2010 to 2013
$418k
Intramural NIH HHS Z01 BC010945
6 · The paper itself

Abstract

objectivePrevious studies have demonstrated the ability of non-lethal doses of radiation to alter the phenotype of tumor cells to facilitate immune mediated killing. This pilot study evaluated the tolerability of a vector-based vaccine targeting carcinoembryonic antigen (CEA) in combination with radiation therapy in patients with gastrointestinal malignancies metastatic to the liver.

methodsPatients enrolled had progressive CEA(+) tumors with metastatic liver lesions. Patients had received a median of three previous chemotherapy regimens, with a median of 2 months since their last chemotherapy regimen. Only 58% had metastatic disease limited to the liver. Vaccination commenced day 1 with biweekly boosters and split-course radiation (total 32 Gy) starting on day 21. Blood was collected at baseline and day 91 for immunological analysis. RESULTS/

conclusionA total of 12 patients were enrolled. There were no grade 3 or greater toxicities or grade 2 or greater hepatic toxicities. Median time on-study was 3 months, with the longest time on treatment being 5 months (n = 2). Immunological analysis was limited to two patients; neither showed an increase above baseline in CEA-specific T cells post-therapy. CEA/TRICOM vaccination in combination with low-dose radiation therapy is safe. There was limited evidence of activity in this patient population.

Indexed as

Genetic VectorsRadiotherapy, ConformalAdultAgedCancer VaccinesCarcinoembryonic AntigenColonic NeoplasmsFowlpox virusHumansLiver NeoplasmsMaleMiddle AgedNational Cancer Institute (U.S.)Pilot ProjectsRadiation DosageRadiotherapy, AdjuvantCancer VaccinesCarcinoembryonic AntigenVaccines, Synthetic

Identifiers

PMID21871012
PMCPMC3513964
OpenAlexW2088478240

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.