The Effectiveness of HP and TMZ Synergism on Adult Recurrence GBM

NCT ID: NCT06218524

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2028-07-31

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.

Conditions

Glioblastoma Multiforme

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TMZ single

Single oral Temozolomide

Group Type: PLACEBO_COMPARATOR

Temozolomide

Intervention Type: DRUG

Temozolomide, 150mg/kg, Oral, Once/Day, 5/28 days

TMZ and Haloperidol

Oral Temozolomide and Haloperidol

Group Type: EXPERIMENTAL

Haloperidol Tablets

Intervention Type: DRUG

Haloperidol tablet 6mg, Oral, Triple/Day

Temozolomide

Intervention Type: DRUG

Temozolomide, 150mg/kg, Oral, Once/Day, 5/28 days

Interventions

Haloperidol Tablets

Haloperidol tablet 6mg, Oral, Triple/Day

Intervention Type: DRUG

Temozolomide

Temozolomide, 150mg/kg, Oral, Once/Day, 5/28 days

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southern Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Yuntao Lu

Professor, Neurosurgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yuntao Lu, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital, Southern Medical University

Central Contacts

Yuntao Lu, Ph.D

Role: CONTACT

lllu2000yun@gmail.com

+86013632101002

References

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 Glioblastoma. Clin Cancer Res. 2023 Aug 15;29(16):3172-3188. doi: 10.1158/1078-0432.CCR-22-3971.

Reference Type: RESULT

PMID: 37249604 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/37249604/

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

Other Identifiers

SEC-DRD2

Identifier Type: -

Identifier Source: org_study_id