The Effectiveness of HP and TMZ Synergism on Adult Recurrence GBM

Glioblastoma Multiforme Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06218524
• Other study ID #: SEC-DRD2
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 1, 2024
• Est. completion date: July 31, 2028

Study information

• Verified date: January 2024
• Source: Southern Medical University, China
• Contact: Yuntao Lu, Ph.D
• Phone: +86013632101002
• Email: lllu2000yun[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: July 31, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Adult patients
• Primary GBM underwent surgery and TMZ chemoradiotherapy, and MRI confirmed the tumor recurrence
• Without severe cardiac diseases

Exclusion Criteria:

• Child patients (<18 years)
• Recurrence tumors grow fast, which needs surgery removal
• H3K27M midline glioblastoma
• Suffered with severe cardiac diseases

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme
• Recurrence

Intervention

Drug:
• Haloperidol Tablets
Haloperidol tablet 6mg, Oral, Triple/Day
• Temozolomide
Temozolomide, 150mg/kg, Oral, Once/Day, 5/28 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Southern Medical University, China

References & Publications (1)

Shi L, Chen H, Chen K, Zhong C, Song C, Huang Y, Wang T, Chen L, Li C, Huang A, Qi S, Li H, Lu Y. The DRD2 Antagonist Haloperidol Mediates Autophagy-Induced Ferroptosis to Increase Temozolomide Sensitivity by Promoting Endoplasmic Reticulum Stress in Glio — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse drug reaction of haloperidol	Detection the adverse drug reaction of haloperidol	One year
Primary	Percentage of partial relief and complete relief	Detected the percentage of partial relief and complete relief according to RANO criteria.	3 months
Secondary	Overall survival	Overall survival was evaluated during follow-up period.	One year
Secondary	DRD2 expression	If the recurrent GBM underwent surgery resection, the DRD2 expression was detected.	One year

External Links

•   Our study about the anti-tumor function of Haloperidol, which was published in Clinical Cancer research.