Evidence map›Paper›PMID 29843811›Full record

Trial reportJournal of translational medicine2018

First results on survival from a large Phase 3 clinical trial of an autologous dendritic cell vaccine in newly diagnosed glioblastoma.

Linda M Liau, Keyoumars Ashkan, David D Tran, Jian L Campian, John E Trusheim, Charles S Cobbs, Jason A Heth, Michael Salacz, Sarah Taylor, Stacy D D'Andre and 59 more

Erratum issued 3 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of translational medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 3 registered trials, which are not on this map. Cited by 353 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
353citing papers in PubMed, 10 pooled it
21.7field-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.

NCT00045968 phase3unknown statusnot on this map

A Phase III Clinical Trial Evaluating DCVax®-L, Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen For The Treatment Of Glioblastoma Multiforme (GBM)

TypeinterventionalSponsorNorthwest BiotherapeuticsRan2006Enrolled348ConditionsGlioblastoma Multiforme, Glioblastoma, GBM, Grade IV AstrocytomaArmsDendritic cell immunotherapy
NCT05270720 phase1unknown statusnot on this mapstarted 2022, after this paper: background citation

Dendritic Cell Vaccination for the Adult Ovarian Cancer

TypeinterventionalSponsorWest China Second University HospitalRan2022 to 2024Enrolled9ConditionsRecurrent Ovarian CancerArmsdendritic cell
NCT05707910 phase1active not recruitingnot on this mapstarted 2023, after this paper: background citation

A Phase I Study of the Efficacy and Safety of Therapeutic Immunological Agent for EBV-positive Advanced Malignant Tumors

TypeinterventionalSponsorWest China HospitalRan2023 to 2027Enrolled6ConditionsMalignant TumorArmsEBV immunological agent
3 · Its place in the literature

Who cites it

353 citing papers in PubMed, 10 syntheses or guidelines pooled it, 531 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
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  4. 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
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293 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

69 authors at 20 institutions in 4 countries.

Linda M LiauUniversity of California Los Angeles (UCLA) David Geffen School of Medicine & Jonsson Comprehensive Cancer Center, Los Angeles, CA, USA. lliau@mednet.ucla.edu.
Keyoumars AshkanKing's College London School of Medical Education, London, UK.
David D TranUniversity of Florida, Gainesville, FL, USA.
Jian L CampianWashington University, St. Louis, MO, USA.
John E TrusheimAbbott Northwestern Hospital, Minneapolis, MN, USA.
Charles S CobbsSwedish Medical Center, Swedish Neuroscience Institute, Seattle, WA, USA.
Jason A HethUniversity of Michigan Medical School, Ann Arbor, MI, USA.
Michael SalaczUniversity of Kansas Cancer Center, Kansas City, KS, USA.
Sarah TaylorUniversity of Kansas Cancer Center, Kansas City, KS, USA.
Stacy D D'AndreSutter Institute for Medical Research, Sacramento, CA, USA.
Fabio M IwamotoColumbia University Medical Center, New York, NY, USA.
Edward J DropchoIndiana University Simon Cancer Center, Indianapolis, IN, USA.
Yaron A MoshelOverlook Medical Center, Summit, NJ, USA.
Kevin A WalterUniversity of Rochester Medical Center, Rochester, NY, USA.
Clement P PillainayagamRush University Medical Center, Rochester, USA.
Robert AikenRutgers Cancer Institute, New Brunswick, NJ, USA.
Rekha ChaudharyUniversity of Cincinnati Medical Center, Cincinnati, OH, USA.
Samuel A GoldlustHackensack University Medical Center, Hackensack, NJ, USA.
Daniela A BotaUC Irvine Medical Center, Irvine, CA, USA.
Paul DuicWinthrop-University Hospital, Mineola, NY, USA.
Jai GrewalNYU Winthrop Hospital, Mineola, NY, USA.
Heinrich ElinzanoRhode Island Hospital, Providence, RI, USA.
Steven A TomsRhode Island Hospital, Providence, RI, USA.
Kevin O LilleheiUniversity of Colorado Hospital, Aurora, CO, USA.
Tom MikkelsenHenry Ford Health System, Detroit, MI, USA.
Tobias WalbertHenry Ford Health System, Detroit, MI, USA.
Steven R AbramSt. Thomas Research Institute, Nashville, TN, USA.
Andrew J BrennerUniversity of Texas Health Science Center, San Antonio, TX, USA.
Steven BremUniversity of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.
Matthew G EwendUniversity of North Carolina, Chapel Hill, NC, USA.
Simon KhagiUniversity of North Carolina, Chapel Hill, NC, USA.
Jana PortnowCity of Hope National Medical Center, Duarte, CA, USA.
Lyndon J KimThomas Jefferson University, Philadelphia, PA, USA.
William G LoudonSt. Joseph Hospital, Newport Beach, CA, USA.
Reid C ThompsonVanderbilt University, Nashville, TN, USA.
David E AviganBeth Israel Deaconess Medical Center, Boston, MA, USA.
Karen L FinkBaylor University Medical Center, Dallas, TX, USA.
Francois J GeoffroyIllinois CancerCare, Peoria, IL, USA.
Scott LindhorstMedical University of South Carolina, Charleston, SC, USA.
Jose LutzkyMount Sinai Comprehensive Cancer Center, Miami, FL, USA.
Andrew E SloanUniversity Hospitals Case Medical Center, Cleveland, OH, USA.
Gabriele SchackertUniversity Hospital Carl-Gustav-Carus of Technical University, Dresden, Germany.
Dietmar KrexUniversity Hospital Carl-Gustav-Carus of Technical University, Dresden, Germany.
Hans-Jorg MeiselBG-Klinikum Bergmannstrost, Halle, Germany.
Julian WuTufts University School of Medicine, Boston, MA, USA.
Raphael P DavisStony Brook University, Stony Brook, NY, USA.
Christopher DumaHoag Cancer Center, Newport Beach, CA, USA.
Arnold B EtameH. Lee Moffit Cancer Center and Research Institute, Tampa, FL, USA.
David MathieuCHUS-Hopital Fleurimont, Sherbrooke University, Sherbrooke, QC, Canada.
Santosh KesariUCSD Health System, UC San Diego, San Diego, CA, USA.
David PiccioniUCSD Health System, UC San Diego, San Diego, CA, USA.
Manfred WestphalNeurochirurgische Klinik University Clinic Hamburg-Eppendorf, Hamburg, Germany.
David S BaskinHouston Methodist, Houston, TX, USA.
Pamela Z NewHouston Methodist, Houston, TX, USA.
Michel LacroixGeisinger Health System, Danville, PA, USA.
Sven-Axel MayKlinikum Chemnitz GGMBH, Chemnitz, Germany.
Timothy J PluardSaint Luke's Cancer Institute, Kansas City, MO, USA.
Victor TseKaiser Permanente Northern California, Redwood City, CA, USA.
Richard M GreenKaiser Permanente Southern California, Los Angeles, CA, USA.
John L VillanoUniversity of Kentucky College of Medicine, Lexington, KY, USA.
Michael PearlmanColorado Neurological Institute, Englewood, CO, USA.
Kevin PetreccaMontreal Neurological Institute and Hospital, McGill University, Montreal, Canada.
Michael SchulderNorthwell Hofstra School of Medicine, Lake Success, NY, USA.
Lynne P TaylorDepartment of Neurology, Alvord Brain Tumor Center, University of Washington, Seattle, WA, USA.
Anthony E MaidaNorthwest Biotherapeutics Inc., Bethesda, MD, USA.
Robert M PrinsUniversity of California Los Angeles (UCLA) David Geffen School of Medicine & Jonsson Comprehensive Cancer Center, Los Angeles, CA, USA.
Timothy F CloughesyUniversity of California Los Angeles (UCLA) David Geffen School of Medicine & Jonsson Comprehensive Cancer Center, Los Angeles, CA, USA.
Paul MulhollandUniversity College Hospitals, London, UK.
Marnix L BoschNorthwest Biotherapeutics Inc., Bethesda, MD, USA. marnix@nwbio.com.ORCID 0000-0002-8831-8456
University of California, Los Angeles · USHenry Ford Health System · USHouston Methodist · USNorthwest Biotherapeutics (United States) · USProvidence College · USThe University of Kansas Cancer Center · USUC San Diego Health System · USUniversity Hospital Carl Gustav Carus · DEUniversity of North Carolina at Chapel Hill · USWinthrop-University Hospital · USAbbott Northwestern Hospital · USBaylor University Medical Center · USBeth Israel Deaconess Medical Center · USBG Klinikum Bergmannstrost Halle · DECity Of Hope National Medical Center · USColorado Neurological Institute · USColumbia University Irving Medical Center · USGeisinger Health System · USHackensack University Medical Center · USHoag Memorial Hospital Presbyterian · US

Funding

UCLA SPORE in Brain CancerP50CA211015 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI David A. Nathanson · 2017 to 2026
$25.2M
NCI NIH HHS P50 CA211015
6 · The paper itself

Abstract

backgroundStandard therapy for glioblastoma includes surgery, radiotherapy, and temozolomide. This Phase 3 trial evaluates the addition of an autologous tumor lysate-pulsed dendritic cell vaccine (DCVax

methodsAfter surgery and chemoradiotherapy, patients were randomized (2:1) to receive temozolomide plus DCVax-L (n = 232) or temozolomide and placebo (n = 99). Following recurrence, all patients were allowed to receive DCVax-L, without unblinding. The primary endpoint was progression free survival (PFS); the secondary endpoint was overall survival (OS).

resultsFor the intent-to-treat (ITT) population (n = 331), median OS (mOS) was 23.1 months from surgery. Because of the cross-over trial design, nearly 90% of the ITT population received DCVax-L. For patients with methylated MGMT (n = 131), mOS was 34.7 months from surgery, with a 3-year survival of 46.4%. As of this analysis, 223 patients are ≥ 30 months past their surgery date; 67 of these (30.0%) have lived ≥ 30 months and have a Kaplan-Meier (KM)-derived mOS of 46.5 months. 182 patients are ≥ 36 months past surgery; 44 of these (24.2%) have lived ≥ 36 months and have a KM-derived mOS of 88.2 months. A population of extended survivors (n = 100) with mOS of 40.5 months, not explained by known prognostic factors, will be analyzed further. Only 2.1% of ITT patients (n = 7) had a grade 3 or 4 adverse event that was deemed at least possibly related to the vaccine. Overall adverse events with DCVax were comparable to standard therapy alone.

conclusionsAddition of DCVax-L to standard therapy is feasible and safe in glioblastoma patients, and may extend survival. Trial registration Funded by Northwest Biotherapeutics; Clinicaltrials.gov number: NCT00045968; https://clinicaltrials.gov/ct2/show/NCT00045968?term=NCT00045968&rank=1 ; initially registered 19 September 2002.

Indexed as

AdultAgedBrain NeoplasmsCancer VaccinesDendritic CellsEndpoint DeterminationFemaleGlioblastomaHumansMaleMiddle AgedPrognosisSurvival AnalysisTreatment OutcomeYoung AdultCancer VaccinesDendritic cellGlioblastomaImmunotherapyVaccine

Identifiers

PMID29843811
PMCPMC5975654
OpenAlexW2805359783

What OpenQuestion holds

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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.