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Chlorpromazine and Standard of Care in Glioblastoma

NCT05190315 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-09-02

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Chlorpromazine

Concurrent Phase: Oral chlorpromazine at 25 mg daily for the first 3 patients, then dose escalate to 50 mg if no dose limiting toxicity (DLT). Starting 7 days prior to radiation start. Interim Phase: Chlorpromazine, 25 mg per day for first 3 subjects and then dose escalate to 50 mg per day if no DLT, will continue post radiation and prior to beginning adjuvant temozolomide. Adjuvant Phase: Chlorpromazine, 25 mg per day for first 3 subjects and then dose escalate to 50 mg per day if no DLT, will be continued daily (7 days per week) concomitant with Temozolomide.

DRUG

Temozolomide

Concurrent Phase: Oral temozolomide at 75 mg/m2 per day concomitant with focal radiation and chlorpromazine. Temozolomide should be started on day 1 of radiation therapy, either at bedtime or morning as per patient preference. Adjuvant Phase: Oral Temozolomide concomitant with Chlorpromazine, starting Temozolomide dose (Cycle 1) is 150 mg/m2 daily with a single dose escalation to 200 mg/m2 daily in subsequent cycles if no treatment-related adverse events \> grade 2 are noted. Temozolomide to be taken once daily for 5 consecutive days (1-5) of a 28 day cycle.

RADIATION

Radiation Therapy

Concurrent Phase: Radiation therapy administered daily, M-F, to a total dose of 60 Gy in 2 Gy Fractions for a total of 30 fractions.

Sponsors & Collaborators

  • Mohammed Milhem

    lead OTHER

Principal Investigators

  • Mohammed Milhem, MBBS · University of Iowa Hospitals and Clinics Holden Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-28
Primary Completion
2023-04-25
Completion
2024-07-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05190315 on ClinicalTrials.gov