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临床试验/NCT06218524
NCT06218524尚未招募2 期

Clinical Study for Evaluating the Effectiveness of Haloperidol and Temozolomide Synergism on Adult Recurrence Glioblastoma

Southern Medical University, China0 个研究点目标入组 200 人开始时间: 2024年12月1日最近更新:
适应症
干预措施
相关药物

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

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

Placebo Comparator

Single oral Temozolomide

干预措施: Temozolomide (Drug)

TMZ and Haloperidol

Experimental

Oral Temozolomide and Haloperidol

干预措施: Haloperidol Tablets (Drug)

TMZ and Haloperidol

Experimental

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

发起方
Southern Medical University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yuntao Lu

Professor, Neurosurgeon

Southern Medical University, China

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