Intratumoral injection of IFN-alpha dendritic cells after dacarbazine activates anti-tumor immunity: Results from a phase I trial in advanced melanoma

Carmela Rozera, Antonini G. Cappellini, Giuseppina D'Agostino, Laura Santodonato, Luciano Castiello, Francesca Urbani, Iole Macchia, Eleonora Aricò, Ida Casorelli, Paola Sestili, Enrica Montefiore, Domenica Monque, Davide Carlei, Mariarosaria Napolitano, Paola Rizza, Federica Moschella, Carla Buccione, Roberto Belli, Enrico Proietti, Antonio PavanPaolo Marchetti, Filippo Belardelli, Imerio Capone

Research output: Contribution to journalArticlepeer-review


Background: Advanced melanoma patients have an extremely poor long term prognosis and are in strong need of new therapies. The recently developed targeted therapies have resulted in a marked antitumor effect, but most responses are partial and some degree of toxicity remain the major concerns. Methods: We tested in a phase I clinical study in advanced melanoma a chemo-immunotherapy approach based on unloaded IFN-DCs injected intratumorally one day after administration of dacarbazine. Primary endpoint of the study was treatment safety and tolerability. Secondary endpoints were immune and clinical responses of patients. Results: Six patients were enrolled, and only three completed the treatment. The chemo-immunotherapy was well tolerated with no major side effects. Three patients showed temporary disease stabilization and two of them showed induction of T cells specific for tyrosinase, NY-ESO-1 and gp100. Of interest, one patient showing a remarkable long-term disease stabilization kept showing presence of tyrosinase specific T cells in PBMC and high infiltration of memory T cells in the tumor lesion at 21 months. Conclusion: We tested a chemo-immunotherapeutic approach based on IFN-DCs injected intratumorally one day after DTIC in advanced melanoma. The treatment was well tolerated, and clinical and immunological responses, including development of vitiligo, were observed, therefore warranting additional clinical studies aimed at evaluating efficacy of this approach. Trial registration: Trial Registration Number not publicly available due to EudraCT regulations:

Original languageEnglish
Article number139
JournalJournal of Translational Medicine
Issue number1
Publication statusPublished - May 2 2015


  • Advanced melanoma
  • Chemo-immunotherapy
  • Dacarbazine
  • Dendritic cells

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)
  • Medicine(all)


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