The Effectiveness of HP and TMZ Synergism on Adult Recurrence GBM

Southern Medical University

Status and phase: Not yet enrolling; Phase 2

Conditions: Glioblastoma Multiforme

Treatments: Drug: Temozolomide; Drug: Haloperidol Tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT06218524

SEC-DRD2

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups, including a placebo group

TMZ single

Placebo Comparator group

Description:

Single oral Temozolomide

Treatment:

Drug: Temozolomide

TMZ and Haloperidol

Experimental group

Description:

Oral Temozolomide and Haloperidol

Treatment:

Drug: Temozolomide

Drug: Haloperidol Tablets