Evidence map›Paper›PMID 26968202›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2016

Pilot and Feasibility Trial Evaluating Immuno-Gene Therapy of Malignant Mesothelioma Using Intrapleural Delivery of Adenovirus-IFNα Combined with Chemotherapy.

Daniel H Sterman, Evan Alley, James P Stevenson, Joseph Friedberg, Susan Metzger, Adri Recio, Edmund K Moon, Andrew R Haas, Anil Vachani, Sharyn I Katz and 14 more

2 registry-linked trialsAbstract readClinical Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 51 papers.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed
9.7field-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.

NCT01119664 phase1completednot on this map

A Pilot And Feasibility Trial Evaluating Two Different Chemotherapy Regimens In Combination With Intrapleural Adenoviral-Mediated Interferon-Alpha Gene Transfer For Malignant Pleural Mesothelioma

TypeinterventionalSponsorAbramson Cancer Center at Penn MedicineRan2010 to 2017Enrolled40ConditionsMesotheliomaArmsSCH 721015
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

51 citing papers in PubMed, 98 citations in OpenAlex.

  1. Review
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  13. Improvements in Systemic Therapies for Advanced Malignant Mesothelioma.International journal of molecular sciences · 2023
    Review
  14. Review
  15. Review
  16. Article
  17. Immunotherapy approaches for malignant pleural mesothelioma.Nature reviews. Clinical oncology · 2022
    Review
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  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

24 authors at 4 institutions in 1 country.

Daniel H StermanDivision of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.
Evan AlleyDivision of Hematology/Oncology, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.
James P StevensonDivision of Hematology/Oncology, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.
Joseph FriedbergDivision of Thoracic Surgery, University of Maryland School of Medicine, Baltimore, Maryland.
Susan MetzgerDivision of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.
Adri RecioDivision of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.
Edmund K MoonDivision of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.
Andrew R HaasDivision of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.
Anil VachaniDivision of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.
Sharyn I KatzDepartment of Radiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.
Jing SunDivision of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.
Daniel F HeitjanDepartment of Biostatistics & Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.
Wei-Ting HwangDepartment of Biostatistics & Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.
Leslie LitzkyDepartment of Pathology and Laboratory Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.
Jennifer H YearleyMerck & Co., Inc., Kenilworth, New Jersey.
Kay See TanDepartment of Biostatistics & Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.
Emmanouil PapasavvasWistar Institute, Philadelphia, Pennsylvania.
Paul KennedyDivision of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.
Luis J MontanerWistar Institute, Philadelphia, Pennsylvania.
Keith A CengelDepartment of Radiation Oncology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.
Charles B SimoneDepartment of Radiation Oncology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.
Melissa CulliganDivision of Thoracic Surgery, University of Maryland School of Medicine, Baltimore, Maryland.
Corey J LangerDivision of Hematology/Oncology, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.
Steven M AlbeldaDivision of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania. albelda@mail.med.upenn.edu.
University of Pennsylvania · USThe Wistar Institute · USUniversity of Maryland, Baltimore · USMerck & Co., Inc., Rahway, NJ, USA (United States) · US

Funding

UNIVERSITY OF PENNSYLVANIA CAN CTR SUPPORT GRANTP30CA016520 · NCI · UNIVERSITY OF PENNSYLVANIA · PI SHELLEY L BERGER · 1985 to 2026
$222.3M
Tumor Microenvironment and MetastasisP30CA010815 · NCI · WISTAR INSTITUTE · PI Luis J Montaner · 1985 to 2026
$75.9M
Translational Research Support CoreP30ES013508 · NIEHS · UNIVERSITY OF PENNSYLVANIA · PI Rebecca A Simmons · 2006 to 2026
$35.3M
TUMOR HYPOXIA, PHOTOSENSITIZER, VASCULARITY AND PDTP01CA087971 · NCI · UNIVERSITY OF PENNSYLVANIA · PI BUSCH, THERESA M, CENGEL, KEITH A · 2001 to 2019
$24.8M
VECTOR DEVELOPMENT /PRECLINICAL TESTINGP01CA066726 · NCI · UNIVERSITY OF PENNSYLVANIA · PI KALOS, MICHAEL D · 1995 to 2016
$18.2M
NCI NIH HHS P01 CA066726NCI NIH HHS P01 CA087971NCI NIH HHS P30 CA010815NCI NIH HHS P30 CA016520NIEHS NIH HHS P30 ES013508
6 · The paper itself

Abstract

purpose"In situ vaccination" using immunogene therapy has the ability to induce polyclonal antitumor responses directed by the patient's immune system. EXPERIMENTAL

designPatients with unresectable malignant pleural mesothelioma (MPM) received two intrapleural doses of a replication-defective adenoviral vector containing the human IFNα2b gene (Ad.IFN) concomitant with a 14-day course of celecoxib followed by chemotherapy. Primary outcomes were safety, toxicity, and objective response rate; secondary outcomes included progression-free and overall survival. Biocorrelates on blood and tumor were measured.

resultsForty subjects were treated: 18 received first-line pemetrexed-based chemotherapy, 22 received second-line chemotherapy with pemetrexed (n = 7) or gemcitabine (n = 15). Treatment was generally well tolerated. The overall response rate was 25%, and the disease control rate was 88%. Median overall survival (MOS) for all patients with epithelial histology was 21 months versus 7 months for patients with nonepithelial histology. MOS in the first-line cohort was 12.5 months, whereas MOS for the second-line cohort was 21.5 months, with 32% of patients alive at 2 years. No biologic parameters were found to correlate with response, including numbers of activated blood T cells or NK cells, regulatory T cells in blood, peak levels of IFNα in blood or pleural fluid, induction of antitumor antibodies, nor an immune-gene signature in pretreatment biopsies.

conclusionsThe combination of intrapleural Ad.IFN, celecoxib, and chemotherapy proved safe in patients with MPM. OS rate was significantly higher than historical controls in the second-line group. Results of this study support proceeding with a multicenter randomized clinical trial of chemo-immunogene therapy versus standard chemotherapy alone. Clin Cancer Res; 22(15); 3791-800. ©2016 AACR.

Indexed as

Genetic TherapyImmunotherapyAdenoviridaeAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCombined Modality TherapyFemaleGenetic VectorsHumansInterferon-alphaLung NeoplasmsMaleMesotheliomaMesothelioma, MalignantMiddle AgedInterferon-alpha

Identifiers

PMID26968202
PMCPMC4970934
OpenAlexW2439888299

What OpenQuestion holds

Textmetadata
LicenceTDM
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.