The Effectiveness of HP and TMZ Synergism on Adult Recurrence GBM
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Haloperidol Tablets, Temozolomide.
- Who it may be relevant to
- Registry conditions: Glioblastoma Multiforme. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Study for Evaluating the Effectiveness of Haloperidol and Temozolomide Synergism on Adult Recurrence Glioblastoma
Overview
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
- Drug Haloperidol Tablets
Haloperidol tablet 6mg, Oral, Triple/Day - Drug Temozolomide
Temozolomide, 150mg/kg, Oral, Once/Day, 5/28 days
Primary outcome measures
- Percentage of partial relief and complete relief [Time frame: 3 months]
Secondary outcome measures (2)
- Overall survival [Time frame: One year]
- DRD2 expression [Time frame: One year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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. PMID 37249604
Identifiers
NCT: NCT06218524 · SEC-DRD2