Clinical Study for Evaluating the Effectiveness of Haloperidol and Temozolomide Synergism on Adult Recurrence Glioblastoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Percentage of partial relief and complete relief
研究概览
简要总结
The study of investigators indicated that TMZ can up-regulate dopamine D2 receptor (DRD2) expression, and mediates Ferroptosis inhibition and chemoresistance of GBM. The clinical data also proved that the DRD2 expression in recurrent GBM is significantly higher than that in primary GBM. Moreover, the DRD2 antagonist haloperidol can attenuate the above function of DRD2, and increase the sensitivity of GBM to the TMZ by inducing fatal autophagy and ferroptosis. In xenograft mice, the combined usage of haloperidol and Temozolomide (TMZ) can significantly inhibit tumor growth and increase overall survival. The investigators' findings have been published in Clinical cancer research. Haloperidol known as a butylbenzene antipsychotic drug, has been widely used in several kinds of mental illnesses, such as depression, schizophrenia, and Bipolar disorder. And the safe dosage of the haloperidol is clear so far. So in this study, the investigators will recruit the patients who suffered from recurrent GBM, and evaluate the effectiveness of single TMZ chemotherapy or combined with haloperidol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients
- •Primary GBM underwent surgery and TMZ chemoradiotherapy, and MRI confirmed the tumor recurrence
- •Without severe cardiac diseases
排除标准
- •Child patients (<18 years)
- •Recurrence tumors grow fast, which needs surgery removal
- •H3K27M midline glioblastoma
- •Suffered with severe cardiac diseases
研究组 & 干预措施
TMZ single
Single oral Temozolomide
干预措施: Temozolomide (Drug)
TMZ and Haloperidol
Oral Temozolomide and Haloperidol
干预措施: Haloperidol Tablets (Drug)
TMZ and Haloperidol
Oral Temozolomide and Haloperidol
干预措施: Temozolomide (Drug)
结局指标
主要结局
Percentage of partial relief and complete relief
时间窗: 3 months
Detected the percentage of partial relief and complete relief according to RANO criteria.
次要结局
- Overall survival(One year)
- DRD2 expression(One year)
研究者
Yuntao Lu
Professor, Neurosurgeon
Southern Medical University, China
