1.0 Introduction 
1.1 Description of Revisions 
This proposal was approved by the Human Gene Therapy 
Subcommittee of the RAC on November 21, 1991. Several 
suggestions were made during the review for modification of the 
protocol. A summary of these modifications are indicated in bold 
on the original application and summarized below: 
1. Clarification regarding the timing of tumor biopsy was 
suggested, including the time of biopsy after gene transfer and 
additional biopsies depending on the response of the injected 
tumor nodule. This information has been described in the revised 
protocol (Sections 6.1, 6.2, and 9.0). Briefly, tumor nodules 
will be biopsied 1 week after initial gene transfer, and, 
subsequently, at the time of repeat injection. Should the 
cutaneous nodule disappear after initial treatment, an additional 
biopsy will be made at the site of injection 2 weeks after 
introduction of the recombinant gene. If the nodule is larger in 
size, an additional biopsy will be performed. In each case, the 
status of HLA-B7 gene expression will be analyzed. The presence 
of nucleic acid will be confirmed by PCR, and the production of 
recombinant HLA-B7 protein will be confirmed by immunostaining. 
The induction of specific immune response against HLA-B7 or 
against the tumor will be assessed with the cytolytic T cell 
assay. The criteria for successful response to treatment are 
also further elaborated (Section 11.1). 
2 . It was suggested that a postmortem examination be 
described in the protocol, with emphasis on pathologic analysis 
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