To hear about similar clinical trials, please enter your email below
Trial Title:
The Effectiveness of HP and TMZ Synergism on Adult Recurrence GBM
NCT ID:
NCT06218524
Condition:
Glioblastoma Multiforme
Conditions: Official terms:
Glioblastoma
Recurrence
Temozolomide
Haloperidol
Haloperidol decanoate
Conditions: Keywords:
Chemoresistance
Autophagy
Ferropotosis
DRD2
Haloperidol
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Haloperidol Tablets
Description:
Haloperidol tablet 6mg, Oral, Triple/Day
Arm group label:
TMZ and Haloperidol
Intervention type:
Drug
Intervention name:
Temozolomide
Description:
Temozolomide, 150mg/kg, Oral, Once/Day, 5/28 days
Arm group label:
TMZ and Haloperidol
Arm group label:
TMZ single
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Start date:
December 1, 2024
Completion date:
July 31, 2028
Lead sponsor:
Agency:
Southern Medical University, China
Agency class:
Other
Source:
Southern Medical University, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06218524
https://pubmed.ncbi.nlm.nih.gov/37249604/
