1. A phase I clinical study of a cocktail vaccine of Wilms' tumor 1 (WT1) HLA class I and II peptides for recurrent malignant glioma.
- Author
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Tsuboi, Akihiro, Hashimoto, Naoya, Fujiki, Fumihiro, Morimoto, Soyoko, Kagawa, Naoki, Nakajima, Hiroko, Hosen, Naoki, Nishida, Sumiyuki, Nakata, Jun, Morita, Satoshi, Sakamoto, Junichi, Oji, Yusuke, Oka, Yoshihiro, and Sugiyama, Haruo
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NEPHROBLASTOMA , *GLIOMAS , *ANTIGENS , *HLA histocompatibility antigens , *CANCER relapse , *CANCER vaccines , *PEPTIDES , *CANCER treatment - Abstract
Purpose: The safety and clinical efficacy of WT1 human leukocyte antigen (HLA) class I peptide vaccine have been established, but the safety of a cocktail vaccine of WT1 HLA class I and II peptides has not. To verify its safety, we performed a phase I clinical trial for patients with recurrent malignant gliomas and assessed the immunological responses and survival data.Patients and methods: Fourteen HLA-A*24:02-positive patients with recurrent malignant glioma (2 with grade 3, 12 with grade 4) were enrolled. Every week, the patients received alternately a vaccine containing 3 mg of WT1 HLA-A*24:02-restricted (HLA class I) peptide and a cocktail vaccine of the HLA class I peptide and one of 0.75, 1.5 or 3 mg of the WT1 HLA class II peptide. For patients who showed no significant adverse effects within 6 weeks, the WT1 vaccine was continued at 2-4-week intervals.Results: Eleven of the 14 patients completed WT1 vaccination for 6 weeks, while 3 patients dropped out earlier due to disease progression. All patients showed grade I level of skin disorders at the injection sites. No grade III/IV toxicity or dose-limiting toxicity was observed for any dose of WT1 HLA class II peptide. Six of the 14 patients had stable disease at 6 weeks. Median OS and 1-year OS rates were 24.7 weeks and 36%, respectively.Conclusion: The safety of a cocktail vaccine of WT1 HLA class I and II peptides for malignant gliomas was verified. This vaccine is, therefore, considered promising for patients with recurrent malignant glioma. [ABSTRACT FROM AUTHOR]
- Published
- 2019
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