As of March 1998, over 150 protocols of cancer gene therapy have been approved and approximately 2, 000 patients have been enrolled in clinical trial mainly in USA and Europe.
As for colorectal cancer, however only a few protocols which include both direct and indirect killing strategies of tumor cells have been approved.
A typical clinical protocol of direct tumor cell killing (suicide gene therapy) utilzing gene of cytosine deaminase which converts 5-FC (nontoxic prodrug) into 5-FU (cytotoxic agent for GI tract) has been started for treatment of multiple liver metastases, though its outcome has not been reported yet. Another direct therapy utilizing the p53 gene has also beeh conducted for liver metastasis, but there isnon information on the results. In animal models, the CEA promotor to drive these cytotoxic genes specfically in CEA expressing tumor has been successfully employed.
As for indirect therapy, the genes for IL-2, IL-7, HLA-B7, and CEA have been utilized to transfect the tumor cell (tumor vaccine), but evaluation of these strategies has not been completed.
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