aSee footnote and abbreviations for Table 2A.

aSee footnote and abbreviations for Table 2A.

tumor progression. The other developed an abscess after the second operation and died. The abscess was unrelated to the VPS injection and was caused by Staphylococcus aureus. Increased HSV-TK enzymatic activity was demonstrated in one tumor specimen. Immunohistochemical confirmation of HSV-TK gene expression was limited only to VPCs, with no detection of activity in tumor cells. Viable tumor cells were seen near HSV-TK-positive VPCs. The lymphocytic immune response was mild (72).

These studies suggested that the HSV-TK gene therapy strategy using retro-viral VPCs appeared safe, although potentially limited by poor transduction, with efficacy evaluation only possible by means of an adequately powered, randomized controlled trial. Such a trial occurred by means of a parallel-group phase III trial involving patients recruited between 1996 and 1998 with untreated glioblastoma multiforme randomized into two groups of 124 patients each. The first group received gross resection of tumor on d 0, followed by 50-60 Gy in 2-Gy fractions starting on d 14-21 and continuing for 6 wk. The second group received HSV-TK VPCs (10 mL at a concentration of 108 VPC/mL) during craniotomy by means of multiple injections 1 cm in depth, separated by 1 cm (73). Progression-free median survival in the gene therapy group was 180 d compared with 183 d in control subjects. Median survival was 365 vs 354 d,

Treatment period

Virus dose

GCV (d)



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