Evidence map›Paper›PMID 28497777›Full record

Trial reportCancer gene therapy2017

Phase I/II clinical trial to assess safety and efficacy of intratumoral and subcutaneous injection of HVJ-E in castration-resistant prostate cancer patients.

K Fujita, Y Nakai, A Kawashima, T Ujike, A Nagahara, T Nakajima, T Inoue, C M Lee, M Uemura, Y Miyagawa and 2 more

Open access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Cancer gene therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
1.3field-weighted citation impact, top 21% 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

13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 23 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Review
  6. Review
  7. Oncolyic Virotherapy for Prostate Cancer: Lighting a Fire in Winter.International journal of molecular sciences · 2022
    Review
  8. Article
  9. Article
  10. Review
  11. Article
  12. Review
  13. Dose Escalation of Vitamin DCancer control : journal of the Moffitt Cancer Center
    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 1 institution in 1 country.

K FujitaDepartment of Urology, Osaka University Graduate School of Medicine, Suita, Japan.
Y NakaiDepartment of Urology, Osaka University Graduate School of Medicine, Suita, Japan.
A KawashimaDepartment of Urology, Osaka University Graduate School of Medicine, Suita, Japan.
T UjikeDepartment of Urology, Osaka University Graduate School of Medicine, Suita, Japan.
A NagaharaDepartment of Urology, Osaka University Graduate School of Medicine, Suita, Japan.
T NakajimaGenomIdea Inc., Osaka, Japan.
T InoueDepartment of Medical Innovation, Osaka University Graduate School of Medicine, Suita, Japan.
C M LeeDepartment of Medical Innovation, Osaka University Graduate School of Medicine, Suita, Japan.
M UemuraDepartment of Urology, Osaka University Graduate School of Medicine, Suita, Japan.
Y MiyagawaDepartment of Urology, Osaka University Graduate School of Medicine, Suita, Japan.
Y KanedaDivision of Gene Therapy Science, Osaka University Graduate School of Medicine, Suita, Japan.
N NonomuraDepartment of Urology, Osaka University Graduate School of Medicine, Suita, Japan.
Osaka University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Inactivated Sendai virus particles (hemagglutinating virus of Japan envelope (HVJ-E)) have a novel antitumor effect: HVJ-E fused to prostate cancer cells via cell surface receptor causes apoptosis of prostate cancer cells in vitro and in vivo. HVJ-E also induces antitumor immunity by activating natural killer (NK) cells and cytotoxic T cells and suppressing regulatory T cells in vivo. We conducted an open-label, single-arm, phase I/II clinical trial in patients with castration-resistant prostate cancer (CRPC) to determine the safety and efficacy of intratumoral and subcutaneous injection of HVJ-E. Patients with CRPC who were docetaxel-resistant or could not receive docetaxel treatment were eligible. HVJ-E was injected directly into the prostate on day 1 and subcutaneously on days 5, 8 and 12 in two 28-day treatment cycles using a 3+3 dose-escalation design. The primary end points were to evaluate safety and tolerability of HVJ-E. The secondary end points were to analyze tumor immunity and antitumor effect. The study is registered at UMIN Clinical Trials Registry, number UMIN000006142. Seven patients were enrolled, and six patients received HVJ-E. Grade 2 or 3 adverse events (Common Terminology Criteria for Adverse Events Ver. 4.0) were urinary retention and lymphopenia from which the patients recovered spontaneously. No Grade 4 adverse events were observed. Radiographically, three patients had stable disease in the low-dose group, and one patient had stable disease and two had progressive disease in the high-dose group. The prostate-specific antigen (PSA) declined from 14 to 1.9 ng ml

Indexed as

AgedAged, 80 and overCytokinesDrug Administration ScheduleHumansInjections, SubcutaneousInterleukinsMaleMiddle AgedProstate-Specific AntigenProstatic Neoplasms, Castration-ResistantSendai virusTherapeuticsVaccines, Virus-Like ParticleViral Envelope ProteinsCytokinesInterleukinsProstate-Specific AntigenVaccines, Virus-Like ParticleViral Envelope Proteins

Identifiers

PMID28497777
PMCPMC5562845
OpenAlexW2612802434

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.