Evidence map›Paper›PMID 19128501›Full record

Trial reportJournal of translational medicine2009

Phase II trial of Modified Vaccinia Ankara (MVA) virus expressing 5T4 and high dose Interleukin-2 (IL-2) in patients with metastatic renal cell carcinoma.

Howard L Kaufman, Bret Taback, William Sherman, Dae Won Kim, William H Shingler, Dorota Moroziewicz, Gail DeRaffele, Josephine Mitcham, Miles W Carroll, Richard Harrop and 2 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
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. It is linked to trial NCT00083941 (Clinical Trial Phase II), which is not on this map. Cited by 38 papers.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed
7.7field-weighted citation impact, top 2% 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.

NCT00083941 phase2completednot on this map

Clinical Trial Phase II (Single Centre Study) : A Preliminary Study of the Safety, Immunogenicity, and Clinical Efficacy of TroVax Given in Conjunction With Interleukin 2 (IL-2) in the Treatment of Stage IV Renal Cell Cancer

TypeinterventionalSponsorOxford BioMedicaRan2004 to 2008Enrolled25ConditionsCarcinoma, Renal CellArmsTroVax, Interleukin-2
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 75 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Review
  6. Review
  7. Review
  8. Antigenic targets in clear cell renal cell carcinoma.Kidney cancer (Clifton, Va.) · 2023
    Review
  9. Review
  10. Article
  11. Review
  12. Article
  13. Review
  14. Novel immunotherapy in metastatic renal cell carcinoma.Investigative and clinical urology · 2017
    Review
  15. Review
  16. Interleukin-2: Old and New Approaches to Enhance Immune-Therapeutic Efficacy.Advances in experimental medicine and biology · 2017
    Review
  17. Article
  18. Review
  19. TroVax in colorectal cancer.Human vaccines & immunotherapeutics · 2014
    Review
  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

12 authors at 2 institutions in 2 countries.

Howard L KaufmanTumor Immunology Laboratory, Division of Surgical Oncology, Columbia University, New York, NY, USA. hlk2003@columbia.edu
Bret Taback
William Sherman
Dae Won Kim
William H Shingler
Dorota Moroziewicz
Gail DeRaffele
Josephine Mitcham
Miles W Carroll
Richard Harrop
Stuart Naylor
Seunghee Kim-Schulze
Columbia University · USOxford BioMedica (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInterleukin-2 (IL-2) induces durable objective responses in a small cohort of patients with metastatic renal cell carcinoma (RCC) but the antigen(s) responsible for tumor rejection are not known. 5T4 is a non-secreted membrane glycoprotein expressed on clear cell and papillary RCCs. A modified vaccinia virus Ankara (MVA) encoding 5T4 was tested in combination with high-dose IL-2 to determine the safety, objective response rate and effect on humoral and cell-mediated immunity.

methods25 patients with metastatic RCC who qualified for IL-2 were eligible and received three immunizations every three weeks followed by IL-2 (600,000 IU/kg) after the second and third vaccinations. Blood was collected for analysis of humoral, effector and regulatory T cell responses.

resultsThere were no serious vaccine-related adverse events. While no objective responses were observed, three patients (12%) were rendered disease-free after nephrectomy or resection of residual metastatic disease. Twelve patients (48%) had stable disease which was associated with improved median overall survival compared to patients with progressive disease (not reached vs. 28 months, p = 0.0261). All patients developed 5T4-specific antibody responses and 13 patients had an increase in 5T4-specific T cell responses. Although the baseline frequency of Tregs was elevated in all patients, those with stable disease showed a trend toward increased effector CD8+ T cells and a decrease in Tregs.

conclusionVaccination with MVA-5T4 did not improve objective response rates of IL-2 therapy but did result in stable disease associated with an increase in the ratio of 5T4-specific effector to regulatory T cells in selected patients. TRIAL REGISTRATION NUMBER: ISRCTN83977250.

Indexed as

AdultAgedAntigens, NeoplasmBiomarkers, TumorCancer VaccinesCarcinoma, Renal CellCD8-Positive T-LymphocytesFemaleHumansInterleukin-2Kaplan-Meier EstimateKidney NeoplasmsMaleMembrane GlycoproteinsMiddle AgedNeoplasm MetastasisAntigens, NeoplasmBiomarkers, TumorCancer VaccinesInterleukin-2Membrane Glycoproteinstrophoblastic glycoprotein 5T4, humanTroVaxVaccines, DNA

Identifiers

PMID19128501
PMCPMC2631474
OpenAlexW2152422810

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.