Metastatic melanoma patients treated with dendritic cell vaccination, Interleukin-2 and metronomic cyclophosphamide: results from a phase II trial
Cancer Immunology, Immunotherapy,

Ellebaek E et al. – The number of patients obtaining stable disease (SD) more than doubled and 6–month survival significantly increased compared to a previous trial without Cyclophosphamide and Celecoxib. A general increase in immune responses against the tested peptides was observed.

Methods
  • Twenty-eight patients with progressive metastatic melanoma were treated with autologous DCs pulsed with survivin, hTERT, and p53-derived peptides (HLA-A2+) or tumor lysate (HLA-A2-).
  • Concomitantly the patients were treated with IL-2, Cyclophosphamide, and Celecoxib.

Results
  • The treatment was safe and tolerable.
  • Sixteen patients (57 %) achieved stable disease (SD) at 1st evaluation and 8 patients had prolonged SD (7-13.7months).
  • The median OS was 9.4months.
  • Patients with SD had an OS of 10.5months while patients with progressive disease (PD) had an OS of 6.0months (p=0.048) even though there were no differences in prognostic factors between the two groups.
  • Despite the use of metronomic Cyclophosphamide, regulatory T cells did not decrease during treatment.
  • Indirect IFN-γ ELISPOT assays showed a general increase in immune responses from baseline to the time of 4th vaccination.
  • Induction of antigen-specific immune responses was seen in 9 out of 15 screened HLA-A2+ patients.

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