JPRN-jRCTs031180148已完成1 期
A phase I/II study for peptides cocktail vaccine in patients with progressive or recurrent malignant glioma.
Toda Masahiro0 个研究点目标入组 17 人开始时间: 2019年2月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
研究概览
简要总结
We performed a pilot study for HLA-A2402+ patients with recurrent/progressive high grade gliomas to assess the safety, feasibility, and immunoreactivity of the peptide-based vaccine targeting LY6K, DEPDC1, KIF20A, FOXM1, VEGFR1, VEGFR2. The safety and immunogenicity of this vaccine therapy was verified. The data suggest that this vaccine treatment may show preliminary evidence of clinical responses.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 16age old 至 <= 79age old（—）
- 性别
- All
入选标准
- •1) malignant glioma.
- •2) HLA-A*2402.
- •3) Age between 16 to 79.
- •4) Performance status (ECOG) of 0-2.
- •5) After the postoperative treatment with temozolomide and irradiation.
- •6) Over 4 weeks after chemotherapy and/or irradiation
- •7) Sufficient function of important organs.
- •8) No uncontrollable pleural, peritoneal or cardiac effusion.
- •9) Expected survival time: more than 3 months.
- •10) Written informed consents are obtained.
排除标准
- •1) Uncontrollable severe infectious diseases.
- •2) Serious concomitant diseases
- •3) Adverse event of NCI-CTC grade 3 or 4.
- •4) Unable to take anything orally over 24 hours.
- •5) Active multiple cancers.
- •6) Myeloproliferative diseases such as MDS and CML.
- •7) After allogeneic hematopoietic stem cell transplantation.
- •8) Active autoimmune diseases.
- •9) Severe drug allergy
- •10) Necessity for administration of steroid or immunosuppressive drugs.
- •11) Pregnancy or lactation. Patients hope pregnancy
- •12) Psychiatric disorders.
- •13) Unhealed injury.
- •14) Judged as inappropriate for this study by doctors.
研究者
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