Evidence map›Paper›PMID 21149657›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2011

Induction of CD8+ T-cell responses against novel glioma-associated antigen peptides and clinical activity by vaccinations with {alpha}-type 1 polarized dendritic cells and polyinosinic-polycytidylic acid stabilized by lysine and carboxymethylcellulose in patients with recurrent malignant glioma.

Hideho Okada, Pawel Kalinski, Ryo Ueda, Aki Hoji, Gary Kohanbash, Teresa E Donegan, Arlan H Mintz, Johnathan A Engh, David L Bartlett, Charles K Brown and 10 more

4 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 344 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
344citing papers in PubMed, 5 pooled it
16.3field-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.

NCT02071095 phase1 / phase2completednot on this mapstarted 2014, after this paper: background citation

Simultaneous Disruption of Latency and Immune Enhancement by Poly-ICLC During HIV-1 Infection

TypeinterventionalSponsorNina BhardwajRan2014 to 2016Enrolled15ConditionsHIV-1 Infected Adults With Chronic HIV-1 InfectionArmsArm A: Poly-ICLC, Arm B: Normal Saline
NCT03262103 phase1completednot on this mapstarted 2017, after this paper: background citation

Phase I Study of In Situ Autologous Vaccination Against Prostate Cancer With Intratumoral and Systemic Hiltonol® (Poly-ICLC) Prior To Radical Prostatectomy

TypeinterventionalSponsorAshutosh Kumar TewariRan2017 to 2022Enrolled13ConditionsProstate CancerArmsIntratumoral (IT) Poly ICLC 0.5 mg, Intratumoral (IT) Poly ICLC 1.0 mg, Intramuscular (IM) Poly ICLC, Radical Prostatectomy
NCT03450044 phase1 / phase2completednot on this mapstarted 2014, after this paper: background citation

Immunogenicity and Safety of Autologous Dendritic Cells in Patients With Breast Cancer Treated With Neoadjuvant Chemotherapy.

TypeinterventionalSponsorFundación Salud de los AndesRan2014 to 2018Enrolled15ConditionsBreast Cancer FemaleArmsDendritic cells
NCT04525859 phase1completednot on this mapstarted 2020, after this paper: background citation

Direct Injection of Poly-ICLC (Hiltonol®) Vaccine In Malignant Pleural Mesothelioma

TypeinterventionalSponsorOncovir, Inc.Ran2020 to 2025Enrolled19ConditionsMalignant Pleural MesotheliomaArmsSafety, Expansion Cohort
3 · Its place in the literature

Who cites it

344 citing papers in PubMed, 5 syntheses or guidelines pooled it, 559 citations in OpenAlex.

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284 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

20 authors at 1 institution in 1 country.

Hideho OkadaG12.a Research Pavilion at the Hillman Cancer Center, 5117 Centre Ave, Pittsburgh, PA 15213-1863, USA. okadah@upmc.edu
Pawel Kalinski
Ryo Ueda
Aki Hoji
Gary Kohanbash
Teresa E Donegan
Arlan H Mintz
Johnathan A Engh
David L Bartlett
Charles K Brown
Herbert Zeh
Matthew P Holtzman
Todd A Reinhart
Theresa L Whiteside
Lisa H Butterfield
Ronald L Hamilton
Douglas M Potter
Ian F Pollack
Andres M Salazar
Frank S Lieberman
UPMC Hillman Cancer Center · US

Funding

University of Pittsburgh Clinical and Translational Science InstituteUL1TR000005 · NCATS · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2012 to 2015
$50.8M
Vector delivery to modify the brain tumor and its microenvironmentP01NS040923 · NINDS · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI GLORIOSO, JOSEPH C · 2002 to 2012
$12.7M
Type-1 Antigen Presenting Cells in CNS Tumors - Key to Efficient Anti-Tumor T-CelP01CA132714 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI KALINSKI, PAWEL · 2009 to 2013
$6.8M
Vaccination With Peptide-loaded alphaDC1s For Malignant GliomasR21CA117152 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI OKADA, HIDEHO · 2007 to 2008
$564k
NCATS NIH HHS UL1 TR000005NCI NIH HHS 1R21CA117152NCI NIH HHS P01 CA132714NCI NIH HHS R21 CA117152NINDS NIH HHS 2P01NS40923NINDS NIH HHS P01 NS040923
6 · The paper itself

Abstract

purposeA phase I/II trial was performed to evaluate the safety and immunogenicity of a novel vaccination with α-type 1 polarized dendritic cells (αDC1) loaded with synthetic peptides for glioma-associated antigen (GAA) epitopes and administration of polyinosinic-polycytidylic acid [poly(I:C)] stabilized by lysine and carboxymethylcellulose (poly-ICLC) in HLA-A2(+) patients with recurrent malignant gliomas. GAAs for these peptides are EphA2, interleukin (IL)-13 receptor-α2, YKL-40, and gp100. PATIENTS AND

methodsTwenty-two patients (13 with glioblastoma multiforme [GBM], five with anaplastic astrocytoma [AA], three with anaplastic oligodendroglioma [AO], and one with anaplastic oligoastrocytoma [AOA]) received at least one vaccination, and 19 patients received at least four vaccinations at two αDC1 dose levels (1 × or 3 × 10(7)/dose) at 2-week intervals intranodally. Patients also received twice weekly intramuscular injections of 20 μg/kg poly-ICLC. Patients who demonstrated positive radiologic response or stable disease without major adverse events were allowed to receive booster vaccines. T-lymphocyte responses against GAA epitopes were assessed by enzyme-linked immunosorbent spot and HLA-tetramer assays.

resultsThe regimen was well-tolerated. The first four vaccines induced positive immune responses against at least one of the vaccination-targeted GAAs in peripheral blood mononuclear cells in 58% of patients. Peripheral blood samples demonstrated significant upregulation of type 1 cytokines and chemokines, including interferon-α and CXCL10. Nine (four GBM, two AA, two AO, and one AOA) achieved progression-free status lasting at least 12 months. One patient with recurrent GBM demonstrated sustained complete response. IL-12 production levels by αDC1 positively correlated with time to progression.

conclusionThese data support safety, immunogenicity, and preliminary clinical activity of poly-ICLC-boosted αDC1-based vaccines.

Indexed as

AdultAgedAntigens, NeoplasmCancer VaccinesCarboxymethylcellulose SodiumCD8-Positive T-LymphocytesCell PolarityDendritic CellsEpitopesFemaleGliomaHumansInterferon InducersInterleukin-12MaleMiddle AgedAntigens, NeoplasmCancer VaccinesCarboxymethylcellulose SodiumEpitopesInterferon InducersInterleukin-12Poly I-Cpoly ICLCPolylysineVaccines, Subunit

Identifiers

PMID21149657
PMCPMC3056467
OpenAlexW2137405984

What OpenQuestion holds

Textmetadata
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.