Evidence map›Paper›PMID 19752336›Full record

ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2009

Phase I active immunotherapy with combination of two chimeric, human epidermal growth factor receptor 2, B-cell epitopes fused to a promiscuous T-cell epitope in patients with metastatic and/or recurrent solid tumors.

Pravin T P Kaumaya, Kevin Chu Foy, Joan Garrett, Sharad V Rawale, Daniele Vicari, Jennifer M Thurmond, Tammy Lamb, Aruna Mani, Yahaira Kane, Catherine R Balint and 7 more

Open access · bronzeAbstract readClinical Trial, Phase I
In one paragraph

Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 2 pooled it
4.6field-weighted citation impact, top 6% 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

43 citing papers in PubMed, 2 syntheses or guidelines pooled it, 84 citations in OpenAlex.

  1. Antigen-specific active immunotherapy for ovarian cancer.The Cochrane database of systematic reviews · 2018
    Pooled it
  2. Is the "3+3" dose-escalation phase I clinical trial design suitable for therapeutic cancer vaccine development? A recommendation for alternative design.Clinical cancer research : an official journal of the American Association for Cancer Research · 2014
    Pooled it
  3. Review
  4. Review
  5. The past, present, and future of immunotherapy for endometrial adenocarcinoma.Medical oncology (Northwood, London, England) · 2023
    Review
  6. Article
  7. Peptides for Vaccine Development.ACS applied bio materials · 2022
    Review
  8. Article
  9. Review
  10. Review
  11. Immuno-Oncology for Gynecologic Malignancies.Advances in experimental medicine and biology · 2021
    Review
  12. Article
  13. Review
  14. Review
  15. Review
  16. Article
  17. Article
  18. Review
  19. 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

17 authors at 1 institution in 1 country.

Pravin T P KaumayaDepartment of Obstetrics and Gynecology, Division of Reproductive Biology and Vaccine Research, Ohio StateUniversity, Columbus, OH 43210, USA. kaumaya.1@osu.edu
Kevin Chu Foy
Joan Garrett
Sharad V Rawale
Daniele Vicari
Jennifer M Thurmond
Tammy Lamb
Aruna Mani
Yahaira Kane
Catherine R Balint
Donald Chalupa
Gregory A Otterson
Charles L Shapiro
Jeffrey M Fowler
Michael R Grever
Tanios S Bekaii-Saab
William E Carson
The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute · US

Funding

Phase 1b Active Immunotherapy with HER-2 Multi-epitope vR21CA094555 · NCI · OHIO STATE UNIVERSITY · PI KAUMAYA, PRAVIN T.P · 2002 to 2003
$656k
NCI NIH HHS CA094555NCI NIH HHS R21 CA094555
6 · The paper itself

Abstract

PURPOSE To evaluate the maximum-tolerated dose (MTD), safety profile, and immunogenicity of two chimeric, B-cell epitopes derived from the human epidermal growth factor receptor (HER2) extracellular domain in a combination vaccine with a promiscuous T-cell epitope (ie, MVF) and nor-muramyl-dipeptide as adjuvant emulsified in SEPPIC ISA 720. PATIENTS AND METHODS Eligible patients with metastatic and/or recurrent solid tumors received three inoculations on days 1, 22, and 43 at doses of total peptide that ranged from 0.5 to 3.0 mg. Immunogenicity was evaluated by enzyme-linked immunosorbent assay, flow cytometry, and HER2 signaling assays. Results Twenty-four patients received three inoculations at the intended dose levels, which elicited antibodies able to recognize native HER2 receptor and inhibited both the proliferation of HER2-expressing cell lines and phosphorylation of the HER2 protein. The MTD was determined to be the highest dose level of 3.0 mg of the combination vaccine. There was a significant increase from dose level 1 (0.5 mg) to dose level 4 (3.0 mg) in HER2-specific antibodies. Four patients (one each with adrenal, colon, ovarian, and squamous cell carcinoma of unknown primary) were judged to have stable disease; two patients (one each with endometrial and ovarian cancer) had partial responses; and 11 patients had progressive disease. Patients with stable disease received 6-month boosts, and one patient received a 20-month boost. CONCLUSION The combination vaccines were safe and effective in eliciting antibody responses in a subset of patients (62.5%) and were associated with no serious adverse events, autoimmune disease, or cardiotoxicity. There was preliminary evidence of clinical activity in several patients.

Indexed as

Adjuvants, ImmunologicAdultAgedAntigens, NeoplasmCancer VaccinesEnzyme-Linked Immunosorbent AssayEpitopes, B-LymphocyteEpitopes, T-LymphocyteErb-b2 Receptor Tyrosine KinasesFemaleFlow CytometryHumansImmunoglobulin GImmunotherapyMaleMaximum Tolerated DoseAdjuvants, ImmunologicAntigens, NeoplasmCancer VaccinesEpitopes, B-LymphocyteEpitopes, T-LymphocyteERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesImmunoglobulin GRecombinant Fusion Proteins

Identifiers

PMID19752336
PMCPMC2773479
OpenAlexW2151912084

What OpenQuestion holds

Textmetadata
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.