Table 2.

Clinical studies of systemic IL-12 in combination with vaccines, other cytokines, or antitumor monoclonal antibodies

TumorsCombined treatmentPatients (n)Objective responseImmune modulationAngiogenesis-related effectsRefs.
Melanoma*gp100 and tyrosinase peptides48NDAge-specific immune response against the peptide vaccine, as shown by ↑IFN-γ release in most patientsND(70)
Melan-A/Mart-1 and influenza peptides288%↑ sIFN-γ within 24 h after the first IL-12 injectionND(71)
Melan-A/Mart-1 peptide-pulsed PBMC2010%↑ IFN-γ–producing T cells directed to Melan-A/Mart-1 after vaccinationND(72)
Melanoma, renal cell carcinoma*IL-22811%↑ IFN-γ production and expansion of NK cells↑ IP-10 production(73)
IFN-α2b2611%CD80 and IFN-γ induction in PBMCs of selected patients by RT-PCRRT-PCR on PBMCs showed induction of IP-10 and IFN-γ in selected patients(74)
HER2+ tumors*Trastuzumab156%↑ IFN-γ production by NK cells in responsive or stable patients; associated with IFN-γ gene polymorphism↑ sMIP-1α, TNF-α and IP-10(75)
  • Abbreviations: PBMC, peripheral blood mononuclear cells; TNF, tumor necrosis factor; NA, not available; ND, not done; s, serum; ↑, increase; ↓, decrease.

  • * Pilot/phase I trial.

  • Phase II trial.