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The Effectiveness of HP and TMZ Synergism on Adult Recurrence GBM

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

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06218524
Enrollment
200
Registered
2024-01-23
Start date
2024-12-01
Completion date
2028-07-31
Last updated
2024-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma Multiforme

Keywords

Chemoresistance, Autophagy, Ferropotosis, DRD2, Haloperidol

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.

Interventions

DRUGHaloperidol Tablets

Haloperidol tablet 6mg, Oral, Triple/Day

DRUGTemozolomide

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

Sponsors

Southern Medical University, China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of partial relief and complete relief3 monthsDetected the percentage of partial relief and complete relief according to RANO criteria.

Secondary

MeasureTime frameDescription
Overall survivalOne yearOverall survival was evaluated during follow-up period.
DRD2 expressionOne yearIf the recurrent GBM underwent surgery resection, the DRD2 expression was detected.

Other

MeasureTime frameDescription
Adverse drug reaction of haloperidolOne yearDetection the adverse drug reaction of haloperidol

Contacts

Primary ContactYuntao Lu, Ph.D
lllu2000yun@gmail.com+86013632101002

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026