Evidence map›Paper›PMID 22498722›Full record

Trial reportCancer gene therapy2012

Phase 1/2a, dose-escalation, safety, pharmacokinetic and preliminary efficacy study of intratumoral administration of BC-819 in patients with unresectable pancreatic cancer.

N Hanna, P Ohana, F M Konikoff, G Leichtmann, A Hubert, L Appelbaum, Y Kopelman, A Czerniak, A Hochberg

Open access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Cancer gene therapy, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 79 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
79citing papers in PubMed, 3 pooled it
4.2field-weighted citation impact, top 5% 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

79 citing papers in PubMed, 3 syntheses or guidelines pooled it, 141 citations in OpenAlex.

  1. Pooled it
  2. Perspectives of long non-coding RNAs in cancer.Molecular biology reports · 2017
    Pooled it
  3. Pooled it
  4. Trial
  5. Review
  6. Review
  7. Article
  8. Review
  9. Review
  10. Current status of endoscopic ultrasound-guided antitumor treatment for pancreatic cancer.Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society · 2025
    Review
  11. Review
  12. Review
  13. Review
  14. Review
  15. Review
  16. The Role of EMT-Related lncRNAs in Ovarian Cancer.International journal of molecular sciences · 2023
    Review
  17. Review
  18. Article
  19. Review
  20. Review

19 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

9 authors at 5 institutions in 2 countries.

N HannaDepartment of Surgery, Division of Surgical Oncology, University of Maryland School of Medicine, Baltimore, MD 21201, USA. nhanna@smail.umaryland.edu
P Ohana
F M Konikoff
G Leichtmann
A Hubert
L Appelbaum
Y Kopelman
A Czerniak
A Hochberg
Hadassah Medical Center · ILTel Aviv University · ILHillel Yaffe Medical Center · ILSheba Medical Center · ILUniversity of Maryland, Baltimore · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BC-819 is a DNA plasmid that was developed to target the expression of diphtheria-toxin gene under the control of H19 regulatory sequences. BC-819 has the potential to treat pancreatic cancer that overexpresses the H19 gene. The objectives were to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of BC-819 administered intratumorally in subjects with unresectable, locally advanced, non-metastatic pancreatic cancer. Nine patients with unresectable pancreatic adenocarcinoma were enrolled in an open-label, dose-escalation trial. Subjects were entered into one out of two cohorts with escalating doses of BC-819. Each cohort received 2 weeks of twice weekly intratumoral injection of BC-819 under computerized tomography (CT) (n = 3) or endoscopic ultrasound (EUS) (n = 6) guidance. Patients were assessed by CT or positron emission tomography (PET)/CT during week 4 for tumor response. The maximum tolerated dose of BC-819 was not reached in this study at the highest dose. Asymptomatic elevation of lipase, which was considered as an adverse event with dose-limiting toxicity, occurred in only one subject in the high-dose group and was resolved spontaneously. The tumors did not increase in size 4 weeks after initiating treatment. Two weeks after completing the treatment, the two subjects who went on to receive subsequent chemotherapy or chemoradiation therapy, pancreatic tumors were downstaged and considered surgically resectable. Remarkably, three of the six subjects in cohort no. 2 evaluated at month 3 had a partial response. BC-819 can be safely administered intratumorally via EUS- or CT-guided injection at a dose of at least 8 mg per injection weekly twice. BC-819 given locally in combination with systemic chemotherapy may provide an additional therapeutic benefit for the treatment of pancreatic cancer.

Indexed as

AdenocarcinomaAgedAged, 80 and overDiphtheria ToxinFemaleGenetic TherapyGenetic VectorsHumansInjections, IntralesionalMaleMaximum Tolerated DoseMiddle AgedMultimodal ImagingPancreatic NeoplasmsPeptide FragmentsPlasmidsDiphtheria Toxindiphtheria toxin fragment AH19 long non-coding RNAPeptide FragmentsRNA, Long NoncodingRNA, Untranslated

Identifiers

PMID22498722
OpenAlexW2037580616

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.