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NCT Number: NCT06218524

The Effectiveness of HP and TMZ Synergism on Adult Recurrence GBM

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Haloperidol Tablets

Drug

Haloperidol tablet 6mg, Oral, Triple/Day

Temozolomide

Drug

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

Primary outcomes

  1. Percentage of partial relief and complete relief

    Time frame: 3 months

    Detected the percentage of partial relief and complete relief according to RANO criteria.

Secondary outcomes

  1. Overall survival

    Time frame: One year

    Overall survival was evaluated during follow-up period.

  2. DRD2 expression

    Time frame: One year

    If the recurrent GBM underwent surgery resection, the DRD2 expression was detected.

Other outcomes

  1. Adverse drug reaction of haloperidol

    Time frame: One year

    Detection the adverse drug reaction of haloperidol

Study contacts

Contact information is provided by the study sponsor or research team.

Yuntao Lu, Ph.D

CONTACT

[email protected]

+86013632101002

Sponsors and collaborators

Lead sponsor

Southern Medical University, China

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jan 23, 2024
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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