Phase-I clinical trial of IL-12 plasmid/lipopolymer complexes for the treatment of recurrent ovarian cancer
Phase-I clinical trial of IL-12 plasmid/lipopolymer complexes for the treatment of recurrent ovarian cancer
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DOI：
10.1038/gt.2009.159
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发表时间：
2010-03-01
期刊：
影响因子：
5.1
通讯作者：
Alvarez, R. D.
中科院分区：
文献类型：
--
作者：
Anwer, K.;Barnes, M. N.;Alvarez, R. D.
在化疗耐药复发性卵巢癌女性患者中进行了一项I期试验，以评估与合成脂质聚合物聚乙二醇-聚乙烯亚胺-胆固醇（PPC）配制的人白细胞介素-12（IL-12）质粒（phIL-12）的安全性和耐受性。总共13名患者被纳入四个剂量递增的队列，每周一次用0.6、3、12或24 mg/m（-2）配制的质粒治疗，持续4周。phIL-12/PPC给药通常安全且耐受性良好。常见的副作用包括低烧和腹痛。在一些患者中临床观察到疾病稳定和血清CA-125水平降低。在整个phIL-12/PPC处理过程中收集的PF样品中可检测到可测量水平的IL-12质粒。相比之下，血清样品要么不含可检测量的质粒DNA，要么含有
A phase-I trial to assess the safety and tolerability of human interleukin-12 (IL-12) plasmid (phIL-12) formulated with a synthetic lipopolymer, polyethyleneglycol-polyethyleneimine-cholesterol (PPC), was conducted on women with chemotherapy-resistant recurrent ovarian cancer. A total of 13 patients were enrolled in four dose-escalating cohorts and treated with 0.6, 3, 12 or 24 mg m(-2) of the formulated plasmid once every week for 4 weeks. Administration of phIL-12/PPC was generally safe and well-tolerated. Common side effects included low-grade fever and abdominal pain. Stable disease and reduction in serum CA-125 levels were clinically observed in some patients. Measurable levels of IL-12 plasmid were detectable in PF samples collected throughout the course of phIL-12/PPC treatment. In comparison, serum samples either did not contain detectable amounts of plasmid DNA or contained