Pilot trial of FANG immunotherapy in ewing's sarcoma

  • Ghisoli M
  • Barve M
  • Schneider R
 et al. 
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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 {\texttimes} 106–2.5 {\texttimes} 107 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/106 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.

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  • Maurizio Ghisoli

  • Minal Barve

  • Reva Schneider

  • Robert Mennel

  • Carl Lenarsky

  • Gladice Wallraven

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