A NOVEL CANCER VACCINE COMPOSED OF HUMAN-RECOMBINANT EPIDERMAL GROWTH-FACTOR LINKED TO A CARRIER PROTEIN - REPORT OF A PILOT CLINICAL-TRIAL

Background: There is evidence of a relationship between epidermal grow th factor (EGF) and tumor cell proliferation, such as the overexpressi on of EGF receptor (EGF-R) in different human tumors, which makes this system an interesting target for cancer treatment. Up to now, passive immunotherapy with monoclonal antibodies against the EGF-R has been a ssayed in clinics. Our approach consists of active immunotherapy with human EGF (hu-EGF). We conducted a pilot clinical trial to define the safety, toxicity and immunogenicity of vaccination with hu-EGF coupled to a carrier protein. Patients and methods: Ten patients with histolo gically-proven malignant carcinomas (colon, lung, stomach and prostate ) in advanced clinical stages were enrolled. Patients were immunized t wice (on days 0 and 25) with hu-EGF linked to either tetanic toroid (T T, five patients) or P64k Neisseria Meningitidis recombinant protein ( P64k, five patients), intradermically, using aluminium hydroxyde as ad juvant. Results. In both groups 60% of patients developed anti-EGF ant ibody titers without evidence of toxicity. Secondary reactions were ve ry mild, limited to erythema and itching at the site of injection, whi ch disappeared without medication. Conclusions: We conclude that the p roposed vaccination with hu-EGF was well tolerated and that antibody t iters against self EGF were developed. The results of this trial may b e useful in the design of new clinical trials with higher dose immuniz ation protocols and using more effective adjuvants.