Evidence map›Paper›PMID 36517865›Full record

Trial reportJournal of experimental & clinical cancer research : CR2022

Phase 2 study of AV-GBM-1 (a tumor-initiating cell targeted dendritic cell vaccine) in newly diagnosed Glioblastoma patients: safety and efficacy assessment.

Daniela A Bota, Thomas H Taylor, David E Piccioni, Christopher M Duma, Renato V LaRocca, Santosh Kesari, Jose A Carrillo, Mehrdad Abedi, Robert D Aiken, Frank P K Hsu and 6 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of experimental & clinical cancer research : CR, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03400917 (Phase II Trial of Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens), which is not on this map. Cited by 42 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 6 pooled it
7.0field-weighted citation impact, top 2% 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.

NCT03400917 phase2unknown statusnot on this map

Phase II Trial of Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens (AV-GBM-1) as an Adjunctive Therapy Following Primary Surgery Plus Concurrent Chemoradiation in Patients With Newly Diagnosed Glioblastoma

TypeinterventionalSponsorAivita Biomedical, Inc.Ran2018 to 2023Enrolled55ConditionsNewly Diagnosed GlioblastomaArmsAV-GBM-1
3 · Its place in the literature

Who cites it

42 citing papers in PubMed, 6 syntheses or guidelines pooled it, 48 citations in OpenAlex.

  1. Autologous tumor lysate-loaded dendritic cell vaccination in glioblastoma patients: a systematic review of literature.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
    Pooled it
  2. Pooled it
  3. A systematic review of immunotherapy in high-grade glioma: learning from the past to shape future perspectives.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024
    Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Trial
  8. Review
  9. Review
  10. Article
  11. Review
  12. Review
  13. Review
  14. Review
  15. Review
  16. Review
  17. Review
  18. Article
  19. Review
  20. Review
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

16 authors at 6 institutions in 1 country.

Daniela A BotaUniversity of California Irvine Department of Neurology and Chao Family Comprehensive Cancer Center, Orange, USA. dbota@hs.uci.edu.ORCID http://orcid.org/0000-0002-9680-9060
Thomas H TaylorUniversity of California Irvine Department of Neurology and Chao Family Comprehensive Cancer Center, Orange, USA.
David E PiccioniUniversity of California San Diego, La Jolla, USA.
Christopher M DumaHoag Hospital and Hoag Neuroscience Institute, Newport, USA.
Renato V LaRoccaNorton Cancer Institute, Louisville, USA.
Santosh KesariJohn Wayne Cancer Institute, and Pacific Neuroscience Institute, Santa Monica, USA.
Jose A CarrilloHoag Hospital and Hoag Neuroscience Institute, Newport, USA.
Mehrdad AbediUniversity of California Davis, Davis, USA.
Robert D AikenRutgers Cancer Center, Brunswick, USA.
Frank P K HsuUniversity of California Irvine Department of Neurology and Chao Family Comprehensive Cancer Center, Orange, USA.
Xiao-Tang KongUniversity of California Irvine Department of Neurology and Chao Family Comprehensive Cancer Center, Orange, USA.
Candace HsiehAIVITA Biomedical, Inc., Irvine, USA.
Peter G BotaAIVITA Biomedical, Inc., Irvine, USA.
Gabriel I NistorAIVITA Biomedical, Inc., Irvine, USA.
Hans S KeirsteadAIVITA Biomedical, Inc., Irvine, USA.
Robert O DillmanAIVITA Biomedical, Inc., Irvine, USA.
University of California, Irvine · USHoag Memorial Hospital Presbyterian · USNorton Healthcare · USRutgers, The State University of New Jersey · USUniversity of California, Davis · USUniversity of California San Diego · US

Funding

Staff InvestigatorsP30CA093373 · NCI · UNIVERSITY OF CALIFORNIA DAVIS · PI Gina M Dayton · 2002 to 2026
$84.9M
NCI NIH HHS P30 CA093373
6 · The paper itself

Abstract

backgroundVaccine immunotherapy may improve survival in Glioblastoma (GBM). A multicenter phase II trial was designed to determine: (1) the success rate of manufacturing the Aivita GBM vaccine (AV-GBM-1), (2) Adverse Events (AE) associated with AV-GBM-1 administration, and (3) survival.

methodsFresh suspected glioblastoma tissue was collected during surgery, and patients with pathology-confirmed GBM enrolled before starting concurrent Radiation Therapy and Temozolomide (RT/TMZ) with Intent to Treat (ITT) after recovery from RT/TMZ. AV-GBM-1 was made by incubating autologous dendritic cells with a lysate of irradiated autologous Tumor-Initiating Cells (TICs). Eligible patients were adults (18 to 70 years old) with a Karnofsky Performance Score (KPS) of 70 or greater, a successful TIC culture, and sufficient monocytes collected. A cryopreserved AV-GBM-1 dose was thawed and admixed with 500 μg of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) before every subcutaneous (s.c.) administration.

resultsSuccess rates were 97% for both TIC production and monocyte collection. AV-GBM-1 was manufactured for 63/63 patients; 60 enrolled per ITT; 57 started AV-GBM-1. The most common AEs attributed to AV-GBM-1 were local injection site reactions (16%) and flu-like symptoms (10%). Treatment-emergent AEs included seizures (33%), headache (37%), and focal neurologic symptoms (28%). One patient discontinued AV-GBM-1 because of seizures. Median Progression-Free Survival (mPFS) and median Overall Survival (mOS) from ITT enrollment were 10.4 and 16.0 months, respectively. 2-year Overall Survival (OS) is 27%.

conclusionsAV-GBM-1 was reliably manufactured. Treatment was well-tolerated, but there were numerous treatment-emergent central nervous system AEs. mPFS was longer than historical benchmarks, though no mOS improvement was noted.

trial registrationNCT, NCT03400917 , Registered 10 January 2018.

Indexed as

Brain NeoplasmsGlioblastomaVaccinesAdolescentAdultAgedAntineoplastic Agents, AlkylatingDendritic CellsHumansMiddle AgedSeizuresTemozolomideTreatment OutcomeYoung AdultAntineoplastic Agents, AlkylatingTemozolomideVaccinesAutologous tumor antigensDendritic cell vaccineGlioblastomaSurvival

Identifiers

PMID36517865
PMCPMC9749349
OpenAlexW4311377823

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.