Evidence map›Paper›PMID 20615924›Full record

Trial reportNeuro-oncology2010

A multi-institution phase II study of poly-ICLC and radiotherapy with concurrent and adjuvant temozolomide in adults with newly diagnosed glioblastoma.

Myrna R Rosenfeld, Marc C Chamberlain, Stuart A Grossman, David M Peereboom, Glenn J Lesser, Tracy T Batchelor, Serena Desideri, Andres M Salazar, Xiaobu Ye

5 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Neuro-oncology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 65 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
65citing papers in PubMed, 1 pooled it
3.6field-weighted citation impact, top 7% 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.

NCT00262730 phase2completednot on this map

A Phase II Trial of Radiation Plus Temozolomide Followed by Adjuvant Temozolomide and Poly-ICLC in Patients With Newly Diagnosed Glioblastoma Multiforme

TypeinterventionalSponsorSidney Kimmel Comprehensive Cancer Center at Johns HopkinsRan2006 to 2010Enrolled97ConditionsGlioblastoma MultiformeArmspoly ICLC, temozolomide, radiation therapy
NCT01984892 phase2terminatednot on this mapstarted 2013, after this paper: background citation

Treatment of Solid Tumors With Intratumoral Hiltonol® (Poly-ICLC): A Phase II Clinical Study

TypeinterventionalSponsorNina BhardwajRan2013 to 2014Enrolled8ConditionsMelanoma, Squamous Cell Carcinoma of the Head and Neck, Squamous Cell Carcinoma of the Skin, Sarcoma of the SkinArmsPoly-ICLC
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
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
NCT04672291 phase1completednot on this mapstarted 2021, after this paper: background citation

A Phase I-Ib, Double-blinded, Randomized Repeated Dose Single Center, Safety and Immunogenicity Study of Nasal Poly-ICLC (Hiltonol®) in Healthy COVID-19 Vaccinated Adults

TypeinterventionalSponsorOncovir, Inc.Ran2021 to 2023Enrolled43ConditionsCOVID - 19ArmsPoly-ICLC (Hiltonol®) or Placebo
3 · Its place in the literature

Who cites it

65 citing papers in PubMed, 1 synthesis or guideline pooled it, 114 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Targeted apoptotic immune modulator for the treatment of metastatic EGFR-positive solid tumors.Proceedings of the National Academy of Sciences of the United States of America · 2025
    Article
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  6. Review
  7. Harnessing innate immune pathways for therapeutic advancement in cancer.Signal transduction and targeted therapy · 2024
    Review
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  11. Review
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  20. Bivalent Genes Targeting of Glioma Heterogeneity and Plasticity.International journal of molecular sciences · 2021
    Review

5 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

9 authors at 5 institutions in 1 country.

Myrna R RosenfeldDepartment of Neurology, 3 W. Gates, University of Pennsylvania, 3400 Spruce St., Philadelphia, PA 19104, USA. myrna.rosenfeld@uphs.upenn.edu
Marc C Chamberlain
Stuart A Grossman
David M Peereboom
Glenn J Lesser
Tracy T Batchelor
Serena Desideri
Andres M Salazar
Xiaobu Ye
Sidney Kimmel Comprehensive Cancer Center · USOncovir (United States) · USAtrium Health Wake Forest Baptist · USCleveland Clinic · USMassachusetts General Hospital · US

Funding

Adult Brain Tumor Consortium (ABTC)U01CA137443 · NCI · JOHNS HOPKINS UNIVERSITY · PI GROSSMAN, STUART A, PRADOS, MICHAEL D · 2009 to 2013
$11.0M
NCI NIH HHS U01 CA137443NCI NIH HHS UO1CA137443
6 · The paper itself

Abstract

The objectives of this study were to determine the safety and efficacy of polyinosinic-polycytidylic acid stabilized with poly-l-lysine and carboxymethylcellulose (poly-ICLC) when added to radiation and temozolomide (TMZ) in adults with newly diagnosed glioblastoma (GB). Patients received external beam radiation with concurrent TMZ (75 mg/m(2)/day) followed by adjuvant TMZ (150-200 mg/m(2)/day for 5 consecutive days once every 9 weeks) and intramuscular poly-ICLC (20 mg/kg/dose given 3× per week for weeks 2-8). An adjuvant cycle was operationally defined as 9 weeks and patients continued adjuvant therapy until toxicity or disease progression. Ninety-seven patients were enrolled (60 men) with a median age of 56 years (range 21-85) and Karnofsky performance status of 90% (range 60%-100%). Fourteen patients did not start adjuvant treatment. Common treatment-related Grade 3-4 toxicities included neutropenia (20.6%), leukopenia (16.5%), thrombocytopenia (9%), and rash (1%). The entire cohort had a median survival of 17.2 months (95% CI: 15.5-19.3 months) with survival at 12, 18, and 24 months of 73.2%, 47.4%, and 29.9%. For subjects 18-70 years old, median overall survival was 18.3 months (95% CI: 15.9-19.8 months), as compared with 14.6 (95% CI: 13.2-16.8) reported by the EORTC 26981/22981 trial. These results demonstrate that poly-ICLC can be added to standard radiation and TMZ in patients with newly diagnosed GB without additional significant toxicities. Survival data at 12 and 18 months suggest that this may improve the efficacy of chemoradiation and adjuvant TMZ in this patient population.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBrain NeoplasmsCarboxymethylcellulose SodiumChemotherapy, AdjuvantCombined Modality TherapyDacarbazineFemaleGlioblastomaHumansInterferon InducersKaplan-Meier EstimateMaleMiddle AgedPoly I-CCarboxymethylcellulose SodiumDacarbazineInterferon InducersPoly I-Cpoly ICLCPolylysineTemozolomide

Identifiers

PMID20615924
PMCPMC3018929
OpenAlexW2113638010

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.