Two phase I studies of low dose recombinant human IL-12 with Melan-A and influenza peptides in subjects with advanced malignant melanoma.
Jonathan Cebon, Elke Jäger, Mark J Shackleton, Peter Gibbs, Ian D Davis, Wendie Hopkins, Sharen Gibbs, Qiyuan Chen, Julia Karbach, Heather Jackson, Duncan P MacGregor, Sue Sturrock, Hilary Vaughan, Eugene Maraskovsky, Antje Neumann, Eric Hoffman, Mathew L Sherman, Alexander Knuth
Cancer Immunity | Published : 2003
Preclinical studies have shown that low dose IL-12 can potentiate cytotoxic lymphocyte responses. Since previous trials have demonstrated significant toxicity from high dose recombinant human IL-12 (rhIL-12), we sought to determine an optimal biological dose for rhIL-12 at lower doses when combined with peptide antigens. Two studies were undertaken. The rhIL-12 was administered at doses of 0 (placebo), 10, 30 and 100 ng/kg, subcutaneously in one study and intravenously in the other. Apart from IL-12 dosing, the studies were identical. Subjects had evaluable stage III or IV melanoma which expressed Melan-A by RT-PCR or immunohistochemistry. Melan-A (26-35) (EAAGIGILTV) and influenza matrix (5..View full abstract