The purpose of the study is the suppression of tumor growth in the liver with less side effects than traditional therapies by transfer of a foreign gene, cytosine deaminase (CD) into cancer cells within the liver. A modified adenovirus is used to transfer this gene. Inside the cancer cells this gene directs the production of CD protein within the cells allowing these cells to convert the nontoxic antibiotic 5-fluorocytosine (5FC) to the active chemotherapeutic agent 5-fluorouracil (5FU) thereby suppressing their growth. Progress report and summary of findings: Part A of this study has entered 6 individuals, 5 of whom have received 2 administrations of the AdgvCD.10 vector, and 1 individual who has received 1 administration. The status of the ongoing patients admitted to the New York Hospital-Cornell Medical Center is summarized in the attached table of adverse events. The first patient, C-01; the fourth patient C-04; and the sixth patient, C-06, have died since their participation in this protocol due to their underlying metastatic colorectal carcinoma. This study is continuing.
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