Abstract

ABSTRACT APPROVAL of the gene-transfer study in cancer patients has been delayed.The proposal was recommended for approval by a National Institutes of Health (NIH) advisory committee, but has been put on hold by James B. Wyngaarden, MD, NIH director, pending submission in writing of further information. Some of this information, now forthcoming, had been withheld because data on preliminary studies had been submitted to peer-reviewed journals.The study involves placing the gene for neomycin-resistance into tumor-infiltrating lymphocytes as a marker. When these cells are injected into the patient, the presence of the marker should enable their fate to be studied over a prolonged period and an improved antitumor regimen could result.The use of tumor-infiltrating lymphocytes as immunotherapy has been studied for two years at the NIH's National Cancer Institute under the overall supervision of Steven A. Rosenberg, MD, chief, Surgery Branch. The patients' tumors are removed and the tumor-infiltrating

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