Direct gene transfer with DNA-liposome complexes in melanoma: expression, biologic activity, and lack of toxicity in humans.
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Discussion
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Implication
Clinical trial demonstrates safe expression and immune response from DNA-liposome complexes in advanced melanoma, indicating the feasibility of direct gene transfer.
Key Points
- Determine the safety, feasibility, and biological activity of direct in vivo gene transfer using DNA-liposome complexes encoding a foreign histocompatibility antigen in patients with advanced melanoma.
- Administered DNA-liposome complexes encoding foreign HLA-B7 via direct intratumoral injection across six treatment courses in five HLA-B7-negative patients with stage IV melanoma.
- Assessed plasmid DNA persistence via polymerase chain reaction and evaluated recombinant protein expression and immune reactivity through tumor biopsies and immunochemistry.
- Plasmid DNA was detected in tumor biopsies 3 to 7 days post-injection in all patients without detectable systemic DNA in serum or development of anti-DNA antibodies.
- Recombinant HLA-B7 protein expression and anti-tumor immune responses were confirmed in all 5 patients, with 1 patient demonstrating regression of injected nodules and distant lesions.
Cite This Study
Nabel et al. (1993) studied this question.