Autor: |
Marcel B. Bally, Hulbert K. B. Silver, Richard Klasa |
Rok vydání: |
1996 |
Předmět: |
|
Zdroj: |
Transfusion Science. 17:169-174 |
ISSN: |
0955-3886 |
DOI: |
10.1016/0955-3886(95)00070-4 |
Popis: |
We are in the process of completing a US FDA and Canadian HPB approved Phase I gene therapy study of malignant melanoma. Careful consideration was given to both gene therapy strategy and the method of transfection. In this very early era of gene therapy, safety dictated the choice of plasmids as a method for gene delivery. Their relatively short term expression would not be an impediment to an immune mediated response. The selection of an allogeneic MHC I gene transfection approach was based on laboratory evidence that this can induce regression in both treated and untreated lesions. The plasmid DNA/lipid mixture was injected six times over 8 weeks directly into a single accessible metastatic melanoma. This schedule is not yet complete in all 7 treated patients and results are preliminary. Local discomfort from injections and biopsies was as expected for these procedures. There were no adverse events attributable to the DNA/lipid mixture. To date plasmid DNA has been detected in five of the seven patients' tumours. Final analysis of DNA expression, immune activation and treatment response are awaiting completion of the study. We are continuing our laboratory investigation of gene therapy strategies and delivery systems as a prelude to further clinical investigation. |
Databáze: |
OpenAIRE |
Externí odkaz: |
|