Evidence map›Paper›PMID 27387678›Full record

ArticleAnnals of surgical oncology2016

Phase 1b Trial to Evaluate Tissue Response to a Second Dose of Intravesical Recombinant Adenoviral Interferon α2b Formulated in Syn3 for Failures of Bacillus Calmette-Guerin (BCG) Therapy in Nonmuscle Invasive Bladder Cancer.

Neema Navai, William F Benedict, Guangcheng Zhang, Alice Abraham, Nancy Ainslie, Jay B Shah, H Barton Grossman, Ashish M Kamat, Colin P N Dinney

Open access · greenAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Annals of surgical oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 2 pooled it
2.8field-weighted citation impact, top 10% 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

24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 35 citations in OpenAlex.

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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 1 institution in 1 country.

Neema NavaiDepartment of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
William F BenedictDepartment of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Guangcheng ZhangDepartment of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Alice AbrahamDepartment of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Nancy AinslieDepartment of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Jay B ShahDepartment of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
H Barton GrossmanDepartment of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Ashish M KamatDepartment of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Colin P N DinneyDepartment of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. cdinney@mdanderson.org.
The University of Texas MD Anderson Cancer Center · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
Targeting Ral GTPases in Bladder CancerP50CA091846 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI DINNEY, COLIN P.N., MCCONKEY, DAVID J. · 2001 to 2018
$37.4M
NCI NIH HHS P30 CA016672NCI NIH HHS P50 CA091846
6 · The paper itself

Abstract

backgroundA phase 1b trial was conducted to evaluate the duration of interferon-alpha (IFNα) production after intravesical administration of recombinant adenovirus-mediated interferon α2b (Ad-IFN) formulated with the excipient Syn3. The primary aim was to determine whether a second instillation 3 days after initial treatment produced prolonged urinary IFN production.

methodsThe study enrolled seven patients who experienced recurrent non-muscle invasive bladder cancer after bacillus Calmette-Guerin therapy. Each treatment consisted of intravesical instillation of SCH721015 (Syn3) and Ad-IFN at a concentration of 3 × 10

resultsSeven patients were treated with an initial course (instillation on days 1 and 4). Two of the patients had a complete response at 12 weeks and received a second course of treatment. One patient remained without evidence of recurrence after a second course (total 24 weeks). One patient experienced a non-treatment-associated adverse event. Despite a transient rise in IFNα levels, sustained production was not demonstrated.

conclusionPreviously, Ad-IFNα intravesical therapy has shown promising drug efficacy. A prior phase 1 trial with a single instillation compared similarly with the current study, suggesting that a second instillation is not necessary to achieve sufficient urinary IFNα levels.

Indexed as

AdenoviridaeAdministration, IntravesicalAgedAged, 80 and overBCG VaccineCholic AcidsDisaccharidesDose-Response Relationship, DrugDrug Administration ScheduleExcipientsGenetic TherapyGenetic VectorsHumansInterferon-alphaInterferon alpha-2MaleBCG VaccineCholic AcidsDisaccharidesExcipientsInterferon-alphaInterferon alpha-2Recombinant ProteinsSyn3 compound

Identifiers

PMID27387678
PMCPMC5459317
OpenAlexW2471695355

What OpenQuestion holds

Textmetadata
LicenceTDM
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.