Tumor suppressor genes are a class of genes whose absence may contribute to tumor growth. In most situations tumor suppressor genes require both alleles of a gene to be deleted or inactivated to lead to tumor growth. The replacement of just one functional tumor suppressor gene may therefore be enough to restore normal growth regulation and induce tumor apoptosis. The tumor suppressor gene with the most clinical trial experience is the gene encoding for wild type (wt)-p53. The wt-p53 gene may inhibit tumor development by either suppressing genes that contribute to uncontrolled cell growth and proliferation or activating genes that inhibit cell growth. Functional p53 is normally responsible for detecting damaged DNA and either directing repair of damaged cells or committing cells to apoptosis (programmed cell death) if the DNA is not able to be repaired. Several wt-p53 gene replacement strategies are in clinical trials for head and neck cancer, melanoma, breast, brain, and lung cancer (13,17,18). An additional advantage to tumor suppressor gene replacement is that normal cells are usually not affected by the tranduction of tumor suppressor genes whereas cancer cells often undergo irreversible apoptosis. This therapeutic index may allow the treatment of cancer cells with minimal toxicity to normal cells.
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