Immunotherapy is playing an increasing role in the treatment of many cancers. The recent advances in antibody therapy gives much optimism that both passive (antibody therapy) as well as active (vaccine therapy) immunotherapeutic interventions will acquire an increasing presence in oncology. Granulocyte macrophage-colony stimulation factor (GM-CSF)-based vaccines have now been tested in several diseases in a variety of formulations. The success and broad applicability of such an approach rests on the development of an ideal vaccine formulation administered in the appropriate clinical context. This review summarizes the results from the clinical trials performed to date and discusses the future directions of GM-CSF-based cellular vaccine strategies aimed at maximizing the therapeutic benefit. (C) 2002 Published by Elsevier Science Ltd.