JPRN-jRCTc030190174已完成1 期
Dendritic cell-based immunotherapy for pediatric refractory brain tumor
Yanagisaw Takaaki0 个研究点目标入组 4 人开始时间: 2020年1月6日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4
研究概览
简要总结
Safety: All 4 patients treated were safe. Efficacy: All four patients showed some response to treatment: two survived without recurrence, one had a recurrence but changed to a very localized pattern of recurrence, and one had a disseminated recurrence that resolved with the treatment. Another patient had a disseminated recurrence, but the primary tumor disappeared after treatment. However, the study was terminated due to implementation problems.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 3age old 至 <= 24age old（—）
- 性别
- All
入选标准
- •Patients will be tentatively enrolled in this clinical trial, when they satisfy the following tentative inclusion criteria.
- •1) A patient who is suspected a relapse or refractory pediatric brain tumor with poor prognosis. 2) A patient who needs to receive a surgical tumor resection. 3) A patient who is tolerable to receive gathering peripheral blood mononuclear cells by an apheresis method. 4) Age at enrollment is 3 to <25 year-old 5) A patient who has grade 0 to 3 of the Performance Status. Patients with a PS score of 4 due to neurological symptoms associated with the primary disease may be eligible if patients could go to outpatient clinic without any respiratory supports. 6) A patient who is suspected to be alive for more than 3 months. 7) A patient who does not have multiple primary cancer. 8) A patient for whom either the legally acceptable representative or the patient (if aged > 16 years) have provided written voluntary consent to participation in this study after fully receiving and understanding the information about this study.
- •9) A patient who satisfies following criteria without functional failure of major organs, such as heart, lung, liver, kidney, and bone marrow etc.
- •Tentatively enrolled patients will be truly enrolled as a subject of this clinical trial, when they satisfy the following final inclusion criteria.
- •1) A patient who is histologically proven recurrent or refractory brain tumor.
- •2) A patient who has autologous cultured tumor cells available to fuse with dendritic cells.
排除标准
- •1) A patient who has sever immune deficiency. 2) A patient who has a past or current history of autoimmune disease. 3) A patient who is administrated immunosuppressive agents for a long period, and is difficult to stop it. 4) A patient who received chemotherapy (including with molecular target therapy) or radiotherapy within 21 days. 5) A patients who underwent allogeneic hematopoietic stem cell transplant. 6) A patient who had recovered from some viral infection (influenza virus or gastroenteritis) within 14 days. 7) A patient who has an allergy to biological medicines. 8) A patient who previously received WT1 peptide vaccine or other immunotherapy (except our dendritic cell vaccine). 9) A patient who has positive of HBs antigen, HIV antibody, HCV antibody, or HTLV antibody. 10) A patient who has severe infectious disease over Grade 3 of CTCAE v4.0. 11) A patient who has sever lung disease (Class 3 or more in the Hugh-Jones classification). 12) A patient who has severe heart disease (Class 3 or more in the NYHA). 13) A patient who has some uncontrollable complication. 14) A pregnant or lactating patient. 15) A patient who is involved in other clinical trials. 16) A patients who are inappropriate for participation in the study for other reasons in the opinion of the investigator or sub-investigator.
研究者
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