The Effectiveness of HP and TMZ Synergism on Adult Recurrence GBM

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06218524
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Southern Medical University, China
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Yuntao Lu, Ph.D
Principal Investigator Affiliation Nanfang Hospital, Southern Medical University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma Multiforme
Study Website: View Trial Website
Arms & Interventions

Arms

Placebo Comparator: TMZ single

Single oral Temozolomide

Experimental: TMZ and Haloperidol

Oral Temozolomide and Haloperidol

Interventions

Drug: - Haloperidol Tablets

Haloperidol tablet 6mg, Oral, Triple/Day

Drug: - Temozolomide

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

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Yuntao Lu, Ph.D

lllu2000yun@gmail.com

+86013632101002

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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