Evidence map›Paper›PMID 11895000›Full record

Trial reportGene therapy2001

Intra-arterial administration of a replication-selective adenovirus (dl1520) in patients with colorectal carcinoma metastatic to the liver: a phase I trial.

T Reid, E Galanis, J Abbruzzese, D Sze, J Andrews, L Romel, M Hatfield, J Rubin, D Kirn

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

Trial report in Gene therapy, 2001. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 80 papers.

0numbers the graph read from it
0cells of the map it votes in
80citing papers in PubMed
13.9field-weighted citation impact, top 1% 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

80 citing papers in PubMed, 243 citations in OpenAlex.

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  13. Oncolytic Viral Therapy for Mesothelioma.Frontiers in oncology · 2017
    Review
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  20. Enhanced CRAd activity using enhancer motifs driven by a nucleosome positioning sequence.Molecular therapy : the journal of the American Society of Gene Therapy · 2013
    Article

20 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 4 institutions in 1 country.

T ReidPalo Alto Veterans Administration Hospital and Stanford University Medical Center, CA, USA.
E Galanis
J Abbruzzese
D Sze
J Andrews
L Romel
M Hatfield
J Rubin
D Kirn
Mayo Clinic in Florida · USMayo Clinic in Arizona · USStanford Medicine · USThe University of Texas MD Anderson Cancer Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Both replication-incompetent and replication-selective adenoviruses are being developed for the treatment of cancer and other diseases. Concerns have been raised about the safety of intra-vascular adenovirus administration following a patient death on a clinical trial with a replication-defective adenovirus. In addition, the feasibility of vascular delivery to distant tumors has been questioned. dl1520 (ONYX-015) is a replication-selective adenovirus that has previously shown safety and antitumoral activity following intratumoral injection. This is the first report of intra-vascular administration with a genetically engineered, replication-selective virus. A phase I dose-escalation trial was performed in patients with liver-predominant gastrointestinal carcinoma (n = 11 total; primarily colorectal). dl1520 was infused into the hepatic artery at doses of 2 x 10(8)-2 x 10(1)2 particles for two cycles (days 1 and 8). Subsequent cycles of dl1520 were administered in combination with intravenous 5-fluorouracil (5-FU) and leucovorin. No dose-limiting toxicity, maximally tolerated dose or treatment-emergent clinical hepatotoxicity were identified following dl1520 infusion. Mild to moderate fever, rigors and fatigue were the most common adverse events. Antibody titers increased significantly in all patients. Viral replication was detectable in patients receiving the highest two doses. An objective response was demonstrated in combination with chemotherapy in a patient who was refractory to both 5-FU and dl1520 as single agents. Therefore, hepatic artery infusion of the attenuated adenovirus dl1520 was well-tolerated at doses resulting in infection, replication and chemotherapy-associated antitumoral activity.

Indexed as

AdenoviridaeAdenovirus E1B ProteinsAgedAntibodies, ViralAntineoplastic Combined Chemotherapy ProtocolsColorectal NeoplasmsCombined Modality TherapyFemaleFluorouracilGene DeletionGenetic TherapyGenome, ViralHepatic ArteryHumansInfusions, Intra-ArterialLeucovorinAdenovirus E1B ProteinsAntibodies, ViralFluorouracilLeucovorin

Identifiers

PMID11895000
PMCPMC7092315
OpenAlexW2036581805

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.