Evidence map›Paper›PMID 14682378›Full record

Trial reportJournal of neuro-oncology2003

Adenovirus/herpes simplex-thymidine kinase/ganciclovir complex: preliminary results of a phase I trial in patients with recurrent malignant gliomas.

Isabelle M Germano, Jennifer Fable, S Humayun Gultekin, Adam Silvers

Abstract readClinical TrialClinical Trial, Phase I
PubMed Publisher
In one paragraph

Trial report in Journal of neuro-oncology, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 63 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
63citing papers in PubMed, 2 pooled it
6.2field-weighted citation impact, top 3% 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

63 citing papers in PubMed, 2 syntheses or guidelines pooled it, 150 citations in OpenAlex.

  1. Pooled it
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  19. Gene Delivery in Neuro-Oncology.Current oncology reports · 2017
    Review
  20. Oncolytic Viral Therapy for Mesothelioma.Frontiers in oncology · 2017
    Review

3 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

4 authors at 1 institution in 1 country.

Isabelle M GermanoDepartment of Neurosurgery, Mount Sinai School of Medicine, New York, NY 10510, USA. isabelle.germano@msnyuhealth.org
Jennifer Fable
S Humayun Gultekin
Adam Silvers
Icahn School of Medicine at Mount Sinai · US

Funding

GENE THERAPY FOR RECURRENT MALIGNANT GLIOMASR03CA082804 · NCI · MOUNT SINAI SCHOOL OF MEDICINE OF NYU · PI GERMANO, ISABELLE M · 1999 to 2000
$83k
NCI NIH HHS NIH-1R03-CA-82804-01
6 · The paper itself

Abstract

The management of patients with glioblastoma remains challenging with an average survival of 32-56 weeks. We report on a clinical trial of patients with recurrent glioblastoma treated with adenovirus/herpex simplex-thymidine kinase/ganciclovir (ADV/HSV-tk/GC). Entry criteria for this study included: recurrent malignant glioma after surgical resection and conventional radiation therapy. At the time of recurrence, computerized volumetric resection of the tumor was performed and the ADV/HSV-tk complex was injected in the tumor bed. GC was administered 24 h after surgery (10 mg/kg/day) for 7 days. Patients were divided into 3 ADV/HSV-tk dose-escalating cohorts. Adenoviral vector shedding, and local or systemic toxicity did not occur in this study. Magnetic resonance imaging showed lack of increased brain edema in the treated patients. Histological examination of the 5 patients that had repeated surgery after gene therapy treatment showed lack of tissue toxicity. Additionally, PCR for HSV-tk was negative in the brain 3 months after injection. The patients' Karnofsky score was maintained > or = 70 in 8/10 patients (80%) and 5/9 patients (55%) 3 and 6 months respectively, after gene therapy. Ten of 11 patients survived > or = 52 weeks from diagnosis with an average survival of 112.3 weeks. One patient is still alive 248 weeks from diagnosis. These data show that the ADV/HSV-tk/GC complex at the dose used in this study is safe. Additional dose escalation is currently in progress.

Indexed as

Genetic TherapyAdenoviridaeAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBrain NeoplasmsCombined Modality TherapyFemaleGanciclovirGenetic VectorsGlioblastomaHumansInjections, IntralesionalMaleMiddle AgedSimplexvirusGanciclovirThymidine Kinase

Identifiers

PMID14682378
OpenAlexW2033642093

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.