Chlorpromazine and Standard of Care in Glioblastoma

PHASE1CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

January 28, 2022

Primary Completion Date

April 25, 2023

Study Completion Date

July 28, 2024

Conditions
Glioblastoma Multiforme
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.

Trial Locations (1)

52242

University of Iowa Hospitals & Clinics, Iowa City

All Listed Sponsors
lead

Mohammed Milhem

OTHER