The benefits and problems associated with clinical application of immunogene therapy with adenovirus harboring the GM-CSF gene

The benefits and problems associated with clinical application of immunogene therapy with adenovirus harboring the GM-CSF gene in the treatment of cancer are described as follows. 1. Vector: The adenoviral vector is useful for immunogene therapy because of its high transduction ability and wide tissue tropism. 2. Safety: Adenovirus has a history of use in vaccines. 3. Efficacy for various cancers: Tumor vaccines could be used for various kinds of cancer cells. 4. Species differences: The problem is that there are no useful human cancer models of immunogene therapy. 5. Evaluation of the clinical protocol: Safety, not efficacy, should be evaluated in a phase 1 study. Since the effects of GM-CSF tumor vaccination on established tumors are unknown, our protocol could be applied to the prevention of local recurrence or metastasis after a relatively or absolutely curative operation.