NATIONAL INSTITUTES of Health (NIH) Clinical Center scientists have taken the first step into a new era of medical therapy by injecting genetically altered human cells into patients with advanced melanoma in order to track and determine the fate of tumor-infiltrating lymphocytes. Ten patients will receive the lymphocytes, cultured from their own tumors and marked with the gene for neomycin resistance for tracking purposes (JAMA. 1989;261: 504).
Approval to start the pioneering NIH study came after reviews by a number of committees and subcommittees over a period of 7 months until James B. Wyngaarden, MD, NIH director, and Frank E. Young, MD, Food and Drug Administration commissioner, gave approval. The study then was held up because of difficulty in getting the neomycin gene into a sufficient number of tumor-infiltrating lymphocytes, says W. French Anderson, MD, a principal investigator.
While Anderson and others were working on this problem, a critic of