Evidence map›Paper›PMID 25917459›Full record

ArticleMolecular therapy : the journal of the American Society of Gene Therapy2015

Pilot Trial of FANG Immunotherapy in Ewing's Sarcoma.

Maurizio Ghisoli, Minal Barve, Reva Schneider, Robert Mennel, Carl Lenarsky, Gladice Wallraven, Beena O Pappen, John LaNoue, Padmasini Kumar, Derek Nemunaitis and 6 more

10 registry-linked trialsOpen access · hybridAbstract read
In one paragraph

Article in Molecular therapy : the journal of the American Society of Gene Therapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 10 registered trials, which are not on this map. Cited by 32 papers.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed
4.5field-weighted citation impact, top 5% 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.

NCT01061840 phase1completednot on this map

Phase I Trial of Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Vaccine for Advanced Cancer

TypeinterventionalSponsorGradalis, Inc.Ran2009 to 2019Enrolled100ConditionsEwings Sarcoma, Non Small Cell Lung Cancer, Liver CancerArmsVigil™
NCT01309230 phase2completednot on this map

Open-label Phase II Trial of Adjuvant bishRNAfurin and GMCSF Augmented Autologous Tumor Cell Vaccine (FANG™) for High Risk Stage III/IV Ovarian Cancer

TypeinterventionalSponsorGradalis, Inc.Ran2011 to 2022Enrolled39ConditionsOvarian CancerArmsVigil™
NCT01505166 phase2terminatednot on this map

Randomized Phase II Trial of Post-operative Adjuvant Chemotherapy ± FANG™ Autologous Tumor Cell Vaccine in Colorectal Carcinoma With Liver Metastases

TypeinterventionalSponsorGradalis, Inc.Ran2012 to 2016Enrolled3ConditionsColon CancerArmsVigil™ Vaccine, Placebo
NCT02346747 phase2active not recruitingnot on this map

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Vigil Engineered Autologous Tumor Cell Immunotherapy in Subjects With Stage IIIb-IV Ovarian Cancer in Clinical Complete Response Following Surgery and Primary Chemotherapy

TypeinterventionalSponsorGradalis, Inc.Ran2015 to 2028Enrolled92ConditionsOvarian Cancer, Ovarian NeoplasmsArmsVigil, Placebo
NCT02511132 phase2completednot on this mapstarted 2016, after this paper: background citation

A 2-part Trial Comparing Overall Survival of Patients With Metastatic Ewing's Sarcoma Treated With Vigil Versus Gemcitabine and Docetaxel and to Determine Safety Profile of Vigil in Combination With Irinotecan and Temozolomide.

TypeinterventionalSponsorGradalis, Inc.Ran2016 to 2020Enrolled22ConditionsEwing's SarcomaArmsVigil, Temozolomide, Irinotecan, Gemcitabine, Docetaxel
NCT02574533 phase1completednot on this map

A Pilot Study of Vigil™ Augmented Autologous Tumor Cell Immunotherapy in Combination With Pembrolizumab PD-1 Inhibitor for Patients With Advanced Melanoma

TypeinterventionalSponsorGradalis, Inc.Ran2015 to 2017Enrolled2ConditionsMelanoma Recurrent, Malignant Melanoma, MelanomaArmsVigil, Pembrolizumab
NCT02639234 phase2withdrawnnot on this mapstarted 2016, after this paper: background citation

A Phase 2 Study of Vigil™ Augmented Autologous Tumor Cell Immunotherapy in Combination With Nivolumab PD-1 Inhibitor for Patients With Advanced Non-Small Cell Lung Cancer

TypeinterventionalSponsorGradalis, Inc.Ran2016 to 2017Enrolled0ConditionsAdvanced Non-small Cell Lung Cancer, Metastatic Non-small Cell Lung Cancer, Lung NeoplasmsArmsVigil™, Nivolumab
NCT03073525 phase2completednot on this mapstarted 2017, after this paper: background citation

A Randomized, Intra-patient Crossover, Safety, Biomarker and Anti-Tumor Activity Assessment of the Combination of Atezolizumab and Vigil in Patients With Advanced Gynecological Cancers (A Companion Study to CL-PTL-119)

TypeinterventionalSponsorGradalis, Inc.Ran2017 to 2022Enrolled25ConditionsAdvanced Gynecological Cancers, Ovarian Cancer, Cervical Cancer, Uterine CancerArmsVigil, Atezolizumab
NCT03495921 phase3terminatednot on this mapstarted 2018, after this paper: background citation

A Multi-Center Phase III, Randomized, Open-Label Trial of Vigil (Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Combination With Irinotecan and Temozolomide as a Second-Line Regimen for Ewing's Sarcoma

TypeinterventionalSponsorGradalis, Inc.Ran2018 to 2022Enrolled32ConditionsEwing Sarcoma, Ewing Family of Tumors, Ewing's Tumor Metastatic, Ewing's Sarcoma MetastaticArmsVigil, Irinotecan, Temozolomide
NCT03842865 temporarily not availablenot on this map

An Expanded Access Trial of Vigil (Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Advanced Solid Tumors

Typeexpanded_accessSponsorGradalis, Inc.ConditionsSolid Tumor, Ewing Sarcoma, Ewing's Tumor Metastatic, Ewing's Sarcoma MetastaticArmsVigil
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 53 citations in OpenAlex.

  1. Trial
  2. Targeted and molecular therapies in Ewing sarcoma: a comprehensive review of preclinical and clinical advances.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review
  3. Review
  4. Review
  5. Development and Prospects of Furin Inhibitors for Therapeutic Applications.International journal of molecular sciences · 2024
    Review
  6. Review
  7. Pilot Study of Recurrent Ewing's Sarcoma Management with Vigil/Temozolomide/Irinotecan and Assessment of Circulating Tumor (ct) DNA.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023
    Article
  8. Review
  9. Review
  10. Review
  11. Article
  12. Review
  13. Review
  14. JNCI cancer spectrum · 2020
    Article
  15. Role of immunotherapy in Ewing sarcoma.Journal for immunotherapy of cancer · 2020
    Review
  16. Review
  17. Review
  18. Review
  19. Review
  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

16 authors at 5 institutions in 1 country.

Maurizio GhisoliMary Crowley Cancer Research Centers, Dallas, Texas, USA; Texas Oncology, P.A., Dallas, Texas, USA; Medical City Dallas Hospital, Dallas, Texas, USA.
Minal BarveMary Crowley Cancer Research Centers, Dallas, Texas, USA; Texas Oncology, P.A., Dallas, Texas, USA.
Reva SchneiderMary Crowley Cancer Research Centers, Dallas, Texas, USA; Texas Oncology, P.A., Dallas, Texas, USA; Gradalis, Inc., Dallas, Texas, USA.
Robert MennelTexas Oncology, P.A., Dallas, Texas, USA; Baylor University Medical Center, Dallas, Texas, USA.
Carl LenarskyTexas Oncology, P.A., Dallas, Texas, USA; Medical City Dallas Hospital, Dallas, Texas, USA.
Gladice WallravenGradalis, Inc., Dallas, Texas, USA.
Beena O PappenGradalis, Inc., Dallas, Texas, USA.
John LaNoueMedical City Children's Hospital, Dallas, Texas, USA.
Padmasini KumarGradalis, Inc., Dallas, Texas, USA.
Derek NemunaitisMary Crowley Cancer Research Centers, Dallas, Texas, USA.
Alyssa RothMary Crowley Cancer Research Centers, Dallas, Texas, USA.
James NemunaitisMary Crowley Cancer Research Centers, Dallas, Texas, USA.
Sam WhitingGradalis, Inc., Dallas, Texas, USA.
Neil SenzerMary Crowley Cancer Research Centers, Dallas, Texas, USA; Gradalis, Inc., Dallas, Texas, USA.
Frederick A FletcherGradalis, Inc., Dallas, Texas, USA.
John NemunaitisMary Crowley Cancer Research Centers, Dallas, Texas, USA; Texas Oncology, P.A., Dallas, Texas, USA; Gradalis, Inc., Dallas, Texas, USA; Medical City Dallas Hospital, Dallas, Texas, USA. Electronic address: jnemunaitis@marycrowley.org.
Gradalis (United States) · USMary Crowley Cancer Research Center · USTexas Oncology · USMedical City Children's Hospital · USMedical City Dallas Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We report on 12 consecutive patients with advanced/metastatic Ewing's sarcoma who were treated as a separate cohort of a phase 1 trial of FANG autologous immunotherapy (1 × 10(6)-2.5 × 10(7) cells/intradermal injection each month for minimum 4 months). Safety and clinical response were monitored. Patient immune response to unmodified autologous tumor cells was assessed by gamma interferon-enzyme-linked immunospot (γIFN-ELISPOT) assay using peripheral blood mononuclear cells from baseline (pretreatment) and multiple postvaccination time points. None of the 12 patients (47 vaccinations) developed grade 2/3/4 drug-related toxicity. Median product release granulocyte-macrophage colony-stimulating factor expression was 1,941 pg/10(6) cells, and TGFβ1and TGFβ2 knockdown were 99 and 100%, respectively. Eight patients were assessed for ELISPOT response to autologous tumor cells at baseline and all (100%) were negative. In contrast, follow-up ELISPOT response at month 1 or month 4 (one patient) after FANG was positive in all eight patients. One patient achieved a partial tumor response (38% tumor reduction, RECIST 1.1). The Kaplan-Meier estimated survival of these 12 patients at 1 year was 75%. In this phase 1 study in patients with Ewing's sarcoma, FANG immunotherapy was well tolerated, elicited a tumor-specific systemic immune response in all patients, and was associated with favorable 1-year survival. Further clinical testing is indicated.

Indexed as

AdolescentAdultFemaleGene Expression RegulationGranulocyte-Macrophage Colony-Stimulating FactorHumansImmunotherapyInterferon-gammaLeukocytes, MononuclearMaleMiddle AgedNeoplasm MetastasisPilot ProjectsSarcoma, EwingTransforming Growth Factor beta1Transforming Growth Factor beta2Granulocyte-Macrophage Colony-Stimulating FactorInterferon-gammaTransforming Growth Factor beta1Transforming Growth Factor beta2

Identifiers

PMID25917459
PMCPMC4817748
OpenAlexW2321142363

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

and 4 more above

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.