Evidence map›Paper›PMID 20033066›Full record

ArticleGene therapy2010

Phase-I clinical trial of IL-12 plasmid/lipopolymer complexes for the treatment of recurrent ovarian cancer.

K Anwer, M N Barnes, J Fewell, D H Lewis, R D Alvarez

Abstract readClinical Trial, Phase IMulticenter Study
PubMed Publisher
In one paragraph

Article in Gene therapy, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 48 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

48 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Review
  6. Article
  7. Review
  8. Review
  9. Review
  10. Targeting cytokine and chemokine signaling pathways for cancer therapy.Signal transduction and targeted therapy · 2024
    Review
  11. Article
  12. Review
  13. Review
  14. Review
  15. Interleukin-12 as an in situ cancer vaccine component: a review.Cancer immunology, immunotherapy : CII · 2022
    Review
  16. Article
  17. Review
  18. GEN-1 in Combination with Neoadjuvant Chemotherapy for Patients with Advanced Epithelial Ovarian Cancer: A Phase I Dose-escalation Study.Clinical cancer research : an official journal of the American Association for Cancer Research · 2021
    Article
  19. Article
  20. Use of Nanoparticles in Delivery of Nucleic Acids for Melanoma Treatment.Methods in molecular biology (Clifton, N.J.) · 2021
    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

5 authors.

K AnwerEGEN Inc, Huntsville, AL 35806, USA.
M N Barnes
J Fewell
D H Lewis
R D Alvarez

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A phase-I trial to assess the safety and tolerability of human interleukin-12 (IL-12) plasmid (phIL-12) formulated with a synthetic lipopolymer, polyethyleneglycol-polyethyleneimine-cholesterol (PPC), was conducted on women with chemotherapy-resistant recurrent ovarian cancer. A total of 13 patients were enrolled in four dose-escalating cohorts and treated with 0.6, 3, 12 or 24 mg m(-2) of the formulated plasmid once every week for 4 weeks. Administration of phIL-12/PPC was generally safe and well-tolerated. Common side effects included low-grade fever and abdominal pain. Stable disease and reduction in serum CA-125 levels were clinically observed in some patients. Measurable levels of IL-12 plasmid were detectable in PF samples collected throughout the course of phIL-12/PPC treatment. In comparison, serum samples either did not contain detectable amounts of plasmid DNA or contained <1% of the amount found in the corresponding PF samples. Treatment-related increases in IFN-gamma levels were observed in PF but not in serum. These data demonstrate that IL-12 gene delivery with a synthetic delivery system is feasible for ovarian cancer patients.

Indexed as

Adenocarcinoma, PapillaryAdultAgedCA-125 AntigenCarcinoma, EndometrioidCholesterolFemaleGenetic TherapyHumansInterferon-gammaInterleukin-12Middle AgedNeoplasm Recurrence, LocalOvarian NeoplasmsPlasmidsPolyethylene GlycolsCA-125 AntigenCholesterolInterferon-gammaInterleukin-12Polyethylene GlycolsPolyethyleneimine

Identifiers

PMID20033066

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.