The Effectiveness of HP and TMZ Synergism on Adult Recurrence GBM

Phase 2

Not yet recruiting

• Conditions: Glioblastoma Multiforme
• Interventions: Drug: Haloperidol Tablets; Drug: Temozolomide

• Registration Number: NCT06218524
• Lead Sponsor: Southern Medical University, China

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-11
• Study First Submitted QC: 2024-01-22
• Last Update Submitted: 2024-01-22
• Study First Posted: 2024-01-23
• Last Update Posted: 2024-01-23
• Study Start: 2024-12-01
• Primary Completion: 2027-12-31
• Study Completion: 2028-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TMZ and Haloperidol	Haloperidol Tablets	Oral Temozolomide and Haloperidol
TMZ single	Temozolomide	Single oral Temozolomide
TMZ and Haloperidol	Temozolomide	Oral Temozolomide and Haloperidol

Primary Outcome Measures

Name	Time	Method
Percentage of partial relief and complete relief	3 months	Detected the percentage of partial relief and complete relief according to RANO criteria.

Secondary Outcome Measures

Name	Time	Method
Overall survival	One year	Overall survival was evaluated during follow-up period.
DRD2 expression	One year	If the recurrent GBM underwent surgery resection, the DRD2 expression was detected.