Evidence map›Paper›PMID 28499389›Full record

Trial reportJournal of translational medicine2017

A phase II trial of autologous dendritic cell vaccination and radiochemotherapy following fluorescence-guided surgery in newly diagnosed glioblastoma patients.

Susana Inogés, Sonia Tejada, Ascensión López-Díaz de Cerio, Jaime Gállego Pérez-Larraya, Jaime Espinós, Miguel Angel Idoate, Pablo Daniel Domínguez, Reyes García de Eulate, Javier Aristu, Maurizio Bendandi and 5 more

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of translational medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01006044 (Prospective, Phase II Clinical Trial to Evaluate Efficacy and Safety of Autologous Dendritic Cell Vaccination in Glioblastoma Multiforme Patients After Complete Surgical Resection With Fluorescence Microscope), which is not on this map. Cited by 95 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
95citing papers in PubMed, 9 pooled it
–field-weighted citation impact
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.

NCT01006044 phase2completednot on this map

Prospective, Phase II Clinical Trial to Evaluate Efficacy and Safety of Autologous Dendritic Cell Vaccination in Glioblastoma Multiforme Patients After Complete Surgical Resection With Fluorescence Microscope

TypeinterventionalSponsorClinica Universidad de Navarra, Universidad de NavarraRan2009 to 2014Enrolled26ConditionsGlioblastoma MultiformeArmsautologous dendritic cells
3 · Its place in the literature

Who cites it

95 citing papers in PubMed, 9 syntheses or guidelines pooled it.

  1. Pooled it
  2. 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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  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
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35 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

15 authors.

Susana InogésCell Therapy Area, Clínica Universidad de Navarra, Avenida Pio XII 36, 31008, Pamplona, Navarra, Spain. sinoges@unav.es.
Sonia TejadaNeurosurgery Department, Clínica Universidad de Navarra, Avenida Pio XII 36, 31008, Pamplona, Navarra, Spain.
Ascensión López-Díaz de CerioCell Therapy Area, Clínica Universidad de Navarra, Avenida Pio XII 36, 31008, Pamplona, Navarra, Spain.ORCID http://orcid.org/0000-0002-7837-135X
Jaime Gállego Pérez-LarrayaNeurology Department, Clínica Universidad de Navarra, Avenida Pio XII 36, 31008, Pamplona, Navarra, Spain.
Jaime EspinósOncology Department, Clínica Universidad de Navarra, Avenida Pio XII 36, 31008, Pamplona, Navarra, Spain.
Miguel Angel IdoatePathology Department, Clínica Universidad de Navarra, Avenida Pio XII 36, 31008, Pamplona, Navarra, Spain.
Pablo Daniel DomínguezRadiology Department, Clínica Universidad de Navarra, Avenida Pio XII 36, 31008, Pamplona, Navarra, Spain.
Reyes García de EulateRadiology Department, Clínica Universidad de Navarra, Avenida Pio XII 36, 31008, Pamplona, Navarra, Spain.
Javier AristuRadiation Oncology Department, Clínica Universidad de Navarra, Avenida Pio XII 36, 31008, Pamplona, Navarra, Spain.
Maurizio BendandiSection on Hematology/Oncology, Department of Internal Medicine, Comprehensive Cancer Center, Wake Forest University Baptist Healthcare Center, Winston-Salem, NC, USA.
Fernando PastorProgram of Molecular Therapies, Aptamer Unit, Centro de Investigación Médica Aplicada (CIMA), Universidad de Navarra, Avenida Pio XII 55, 31008, Pamplona, Navarra, Spain.
Marta AlonsoProgram in Solid Tumors and Biomarkers, Centro de Investigación Médica Aplicada (CIMA), Universidad de Navarra, Avenida Pio XII 55, 31008, Pamplona, Navarra, Spain.
Enrique AndreuImmunology and Immunotherapy Department, Clínica Universidad de Navarra, Avenida Pio XII 36, 31008, Pamplona, Navarra, Spain.
Felipe Prósper CardosoCell Therapy Area, Clínica Universidad de Navarra, Avenida Pio XII 36, 31008, Pamplona, Navarra, Spain.
Ricardo Díez ValleNeurosurgery Department, Clínica Universidad de Navarra, Avenida Pio XII 36, 31008, Pamplona, Navarra, Spain. rdiezvalle@unav.es.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPrognosis of patients with glioblastoma multiforme (GBM) remains dismal, with median overall survival (OS) of about 15 months. It is therefore crucial to search alternative strategies that improve these results obtained with conventional treatments. In this context, immunotherapy seems to be a promising therapeutic option. We hypothesized that the addition of tumor lysate-pulsed autologous dendritic cells (DCs) vaccination to maximal safe resection followed by radiotherapy and concomitant and adjuvant temozolomide could improve patients' survival.

methodsWe conducted a phase-II clinical trial of autologous DCs vaccination in patients with newly diagnosed patients GBM who were candidates to complete or near complete resection. Candidates were finally included if residual tumor volume was lower than 1 cc on postoperative radiological examination. Autologous DCs were generated from peripheral blood monocytes and pulsed with autologous whole tumor lysate. The vaccination calendar started before radiotherapy and was continued during adjuvant chemotherapy. Progression free survival (PFS) and OS were analyzed with the Kaplan-Meier method. Immune response were assessed in blood samples obtained before each vaccines.

resultsThirty-two consecutive patients were screened, one of which was a screening failure due to insufficient resection. Median age was 61 years (range 42-70). Karnofsky performance score (KPS) was 90-100 in 29%, 80 in 35.5% and 60-70 in 35.5% of cases. MGMT (O

conclusionsOur results suggest that the addition of tumor lysate-pulsed autologous DCs vaccination to tumor resection and combined radio-chemotherapy is feasible and safe. A multicenter randomized clinical trial is warranted to evaluate the potential survival benefit of this therapeutic approach. Trial registration This phase-II trial was registered as EudraCT: 2009-009879-35 and ClinicalTrials.gov Identifier: NCT01006044 retrospectively registered.

Indexed as

ChemoradiotherapyVaccinationAdultAgedBrain NeoplasmsCombined Modality TherapyCytokinesDendritic CellsDisease-Free SurvivalFeasibility StudiesFemaleFluorescenceGlioblastomaHumansInflammationMaleCytokinesDendritic cellGlioblastomaImmunotherapyOverall survival

Identifiers

PMID28499389
PMCPMC5427614

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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.