Chlorpromazine and Standard of Care in Glioblastoma

Glioblastoma Multiforme Clinical Trial

Official title: A Phase I Trial of Chlorpromazine Together With Standard of Care in New Diagnosis of Glioblastoma

Status Active, not recruiting

Clinical Trial Summary

This is a phase 1 study investigating the re-purposing of chlorpromazine, combined with temozolomide and radiation in the treatment of newly diagnosed glioblastoma multiforme.

Clinical Trial Description

The purpose of the study is to determine the safety and acute toxicity of chlorpromazine (CPZ) when administered throughout the standard treatment protocol for glioblastoma multiforme, as well as determine progression free survival.

Chlorpromazine (25 mg daily for the first 3 patients then dose escalate to 50 mg if no DLT) will be added to a standard of care regimen which includes radiation and adjuvant Temozolomide. Chlorpromazine treatment will continue for up to 6 cycles or until criteria for removal is met. Temozolomide is administered following standard practice adopted at the University of Iowa Hospitals and Clinics (UIHC).

Subject will have several MRI scans for disease assessment throughout the treatment. There will be 3 phases of treatment for each patient:

Concomitant Chlorpromazine- Start 7 days prior to day 1 of concurrent Temozolomide and radiation. Will continue with Chlorpromazine through radiation therapy (temozolomide will cease after 49 days)

Interim Phase- When radiation has ended, subject will take Chlorpromazine for 28 days- no Temozolomide

Adjuvant phase- subject resumes Temozolomide per standard practice, and continues to take Chlorpromazine through 6 cycles of Temozolomide. ;

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

• NCT number: NCT05190315
• Study type: Interventional
• Source: University of Iowa
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: January 28, 2022
• Completion date: July 2024