Four protocols were approved unanimously in such quicksuccession today that for once, the recombinant DNA advisorycommittee (RAC) of the National Institutes of Health (NIH)found itself well ahead of schedule by lunch time.
The first protocol approved was a phase I study of transfectedcancer cells expressing the interleukin-2 gene product inlimited stage small-cell lung cancer (which had been deferredat the last RAC meeting) sponsored by researchers at theUniversity of Miami School of Medicine.
A protocol sponsored by Joyce OUShaughnessy of the NIH wasthen approved. The protocol involves retroviral insertion of thehuman multi-drug resistance gene into hematopoietic stemcells during autologous transplantation after intensivechemotherapy for breast cancer.
A major modification of a phase I protocol to evaluate thesafety of cellular adoptive immunotherapy using geneticallymodified CD8 positive HIV-specific T cells in HIV seropositiveindividuals was next up approved. It was sponsored byresearchers at the Fred Hutchinson Cancer Research Center inSeattle
The final approval of the day was a protocol concerning genetherapy for recurrent pediatric brain tumors sponsored byresearchers at St. Jude ChildrenUs Research Hospital in Memphisand Edward H. Oldfield at the NIH (Genetic Therapy Inc. ofGaithersburg, Md., contributed a retroviral vector, HS-tk, whichcarries a gene for drug sensitivity).
In a special motion, the RAC voted unanimously to set up aworking group to address the problem of writing morecomprehensible informed consent documents.-- David C. Holzman
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