Combined HSV-TK/IL-2 gene therapy in patients with recurrent glioblastoma multiforme: biological and clinical results.

摘要: Following our pilot clinical study of combined IL-2/HSV-TK gene therapy for recurrent glioblastoma multiforme (GBM), we extended the protocol to a larger population patients and evaluated safety, feasibility, biological activity treatment. A total 12 received intratumor injection retroviral vector-producing cells (RVPCs), followed by intravenous ganciclovir (GCV). Treatment was well tolerated with only minor adverse events. Transduction tumor demonstrated in biopsies. marked persistent increase plasma Th1 cytokine levels after RVPC injection. At magnetic resonance imaging evaluation, two had partial response (including patient showing disappearance distant noninjected mass), four response, stable disease, progressive disease. The 6- 12-month progression-free survival rates were 47 14%, respectively. overall 58 25%, In conclusion, results GBM, based on delivery suicide gene, demonstrate that RVPCs safe, provided effective transduction therapeutic genes target cells, activated systemic cascade, responses 50% cases.