Evidence map›Paper›PMID 16410826›Full record

Trial reportCancer gene therapy2006

Phase 1/2 trial of autologous tumor mixed with an allogeneic GVAX vaccine in advanced-stage non-small-cell lung cancer.

J Nemunaitis, T Jahan, H Ross, D Sterman, D Richards, B Fox, D Jablons, J Aimi, A Lin, K Hege

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Cancer gene therapy, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01258868 (Epigenetically-Modified Autologous Tumor Cell Vaccines With ISCOMATRIX), which is not on this map. Cited by 81 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
81citing papers in PubMed, 2 pooled it
6.0field-weighted citation impact, top 3% 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.

NCT01258868 phase1terminatednot on this mapstarted 2010, after this paper: background citation

Epigenetically-Modified Autologous Tumor Cell Vaccines With ISCOMATRIX(TM) Adjuvant and Oral Celecoxib in Patients Undergoing Resection of Lung and Esophageal Cancers, Thymic Neoplasms, Thoracic Sarcomas, and Malignant Pleural Mesotheliomas

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2010 to 2016Enrolled44ConditionsMesolthelioma, Esophageal Cancer, Lung Cancer, Thoracic SarcomasArmsCelebrex, Tumor cell vaccine
3 · Its place in the literature

Who cites it

81 citing papers in PubMed, 2 syntheses or guidelines pooled it, 176 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. K562/GM-CSF immunotherapy reduces tumor burden in chronic myeloid leukemia patients with residual disease on imatinib mesylate.Clinical cancer research : an official journal of the American Association for Cancer Research · 2010
    Trial
  7. Trial
  8. Review
  9. Review
  10. Review
  11. Review
  12. Therapeutic Vaccination in Lung Cancer: Past Attempts, Current Approaches and Future Promises.Journal of respiratory biology and translational medicine · 2025
    Article
  13. Cracking the Codes behind Cancer Cells' Immune Evasion.International journal of molecular sciences · 2024
    Review
  14. Article
  15. Review
  16. Article
  17. Vaccinating against cancer: getting to prime time.Journal for immunotherapy of cancer · 2023
    Review
  18. Article
  19. Review
  20. Article

21 more citing papers are in PubMed but not listed here.

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

10 authors at 6 institutions in 1 country.

J NemunaitisMary Crowley Medical Research Center, Baylor University Medical Center, Texas Oncology PA, Dallas, TX 75201, USA. jnemunaitis@mcmrc.com
T Jahan
H Ross
D Sterman
D Richards
B Fox
D Jablons
J Aimi
A Lin
K Hege
Genesys (United States) · USProvidence Portland Medical Center · USUniversity of California, San Francisco · USBaylor University Medical Center · USMary Crowley Cancer Research Center · USUniversity of Pennsylvania · US

Funding

The Wnt Pathway in Malignant MesotheliomaR01CA093708 · NCI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI JABLONS, DAVID M. · 2005 to 2008
$883k
NCI NIH HHS R01 CA093708
6 · The paper itself

Abstract

Tumor vaccines composed of autologous tumor cells genetically modified to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF) (GVAX) have demonstrated clinical activity in advanced-stage non-small-cell lung cancer (NSCLC). In an effort to remove the requirement for genetic transduction of individual tumors, we developed a 'bystander' GVAX platform composed of autologous tumor cells mixed with an allogeneic GM-CSF-secreting cell line. We conducted a phase I/II trial of this vaccine (3-12 biweekly vaccinations) in advanced-stage NSCLC. Tumors were harvested from 86 patients, tumor cell processing was successful in 76, and 49 proceeded to vaccination. The most common toxicity was local vaccine injection site reactions. Serum GM-CSF pharmacokinetics were consistent with secretion of GM-CSF from vaccine cells for up to 4 days with associated transient leukocytosis confirming the bioactivity of vaccine-secreted GM-CSF. Evidence of vaccine-induced immune activation was demonstrated; however, objective tumor responses were not seen. Compared with autologous GVAX vaccines prepared by transduction of individual tumors with an adenoviral GM-CSF vector, vaccine GM-CSF secretion was approximately 25-fold higher with the bystander GVAX vaccine used in this trial. However, the frequency of vaccine site reactions, tumor response, time to disease progression, and survival were all less favorable in the current study.

Indexed as

AdultAgedCancer VaccinesCarcinoma, Non-Small-Cell LungFemaleGranulocyte-Macrophage Colony-Stimulating FactorHumansK562 CellsLung NeoplasmsMaleMiddle AgedNeoplasm StagingPatient SelectionTransplantation, HomologousTreatment OutcomeTumor Cells, CulturedCancer VaccinesGranulocyte-Macrophage Colony-Stimulating Factor

Identifiers

PMID16410826
OpenAlexW2021896163

What OpenQuestion holds

Textmetadata
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.