JPRN-jRCTc040190103已完成2 期
Dendritic cell-based tumor-specific immunotherapy against malignant brain tumor - Phase II clinical trial - Immunotherapy against malignant brain tumor
Akiyama Yasuto0 个研究点目标入组 16 人开始时间: 2020年1月7日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
研究概览
简要总结
Sixteen newly diagnosed patients with high-grade gliomas were enrolled in a phase II study of the alpha-type-1 DC vaccine. Among 16 patients, 10 showed positive CTL responses to any peptides in an ELISPOT assay. Adverse effects were limited to grade 2 levels. After 6 years of observation, five patients were still alive. Moreover, a significant survival-prolonging effect was verified in DC-treated glioma patients. Peptide-pulsed alpha-type-1 DC vaccines have a potential therapeutic effect on survival.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 80age old（—）
- 性别
- All
入选标准
- •1. Histolog ical diagnosis of high-grade glioma (WHO Gr3-4)
- •2. Standard chemoradiation treatment is supposed to be given after surgery
- •3. 20< age<80
- •4. Performance status 0-2
- •5. Measurable lesions by imaging diagnosis
- •6. HLA-g enotyping : HLA-A2 or A24
- •7. No severe organ dysfunction
- •8. Tolerable and eligible to apheresis performance
- •9. No severe hemostatic disorders
- •10. Informed consents obtained
- •11. Expecting survival with more than 6 months
- •12. Over 4-week interval after the previous treatment
排除标准
- •1. Within 28 days after the last cancer treatment
- •2. Severe systemic infection, hemostatic dysfunction and organ disorders
- •3. Steroid treatment except used for cerebral decompression
- •4. Pregnant women
- •5. Hypersensitivity to dendritic cell vaccines
- •6. Severe immunolog ical disorders (autoimmune disease, immunosuppression)
- •7. Multiple cancers
- •8. Anaphylaxis to synthetic peptides
研究者
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