The evolving understanding of the molecular mechanisms of carcinogenesis establishes that the long latency period would offer numerous opportunities for intervention before the final step of fully developed malignancy has been reached. Immunoprevention of cancer may be a new approach to cancer control, by eliminating the cellular minimal deviations that are seen in the early phases of carcinogenesis. Available results of immunotherapy of preneoplastic lesions and data on anticarcinogenesis with immunoregulators in experimental models are in good accordance with theoretical expectations. However, clinical research on immunoregulators still focuses on the treatment of advanced cancer. The major problem hampering a wider application of immunoregulators in cancer prevention is the possibility of potential adverse effects, which are largely unknown. The promotion of future research in this area is essential. Moreover, the ethical issues of intervention trials in cancer must be discussed, by considering the potential psychological and social consequences.