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Phenothiazine Antipsychotic

Chlorpromazine and Standard of Care for Glioblastoma

Phase 1
Waitlist Available
Led By Mohammed Milhem, MBBS
Research Sponsored by Varun Monga, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis must be made by surgical biopsy or excision.
ECOG performance status 0-2 (Karnofsky > 50%, see Appendix B).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing if a drug used to treat schizophrenia can also be used to treat brain cancer.

Who is the study for?
This trial is for adults over 18 with newly diagnosed glioblastoma who have had recent surgery. They must be in a stable condition (ECOG 0-2), with good blood counts and liver function, and able to give informed consent. Excluded are those with heart issues, prior high-grade glioma treatments, other CNS diseases or malignancies that could affect the study, uncontrolled illnesses, or pregnant/breastfeeding women.Check my eligibility
What is being tested?
The study tests chlorpromazine combined with temozolomide and radiation therapy as a new treatment approach for glioblastoma multiforme. It's an early-phase trial to see if this repurposed drug can work well alongside standard cancer treatments.See study design
What are the potential side effects?
Potential side effects may include typical reactions from chemotherapy like nausea, fatigue, low blood cell counts leading to increased infection risk; radiation therapy might cause skin irritation or hair loss at the treated site; chlorpromazine can cause drowsiness, dry mouth or blurred vision.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My diagnosis was confirmed through a surgical procedure.
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I can take care of myself but might not be able to do heavy physical work.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recommended phase II dose of chlorpromazine in combination with the standard treatment protocol for glioblastoma
Safety and acute toxicity of chlorpromazine (CPZ) when administered throughout the standard treatment for glioblastoma multiforme (GBM) will be graded per NCI's Common Terminology Criteria for Adverse Events v 5.0 (CTCAE v5.0)
Secondary outcome measures
2-year overall survival of patients with newly diagnosed GBM treated with CPZ and standard chemoradiation 6 months from the date of surgery
Glioblastoma

Side effects data

From 2010 Phase 3 trial • 388 Patients • NCT00882518
25%
Constipation
14%
Dizziness
13%
Insomnia
12%
Agitation
9%
Extrapyramidal Disorder
8%
Somnolence
6%
Palpitations
6%
Upper respiratory tract infection
6%
Diarrhea
6%
Hepatic Function Abnormal
5%
Tachycardia
4%
Heart rate increased
3%
Nasopharyngitis
2%
Orthostatic Hypotension
2%
Akathisia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)
Chlorpromazine

Trial Design

1Treatment groups
Experimental Treatment
Group I: Chlorpromazine with standard of care chemoradiationExperimental Treatment3 Interventions
Each patient will undergo 3 phases of treatment. Concurrent Phase: includes concurrent radiation Monday - Friday (60 Gy total radiation dose in 2 Gy fractions), oral temozolomide (75 mg/m2/day) daily for a maximum 49 days starting Day 1 of radiation, and oral chlorpromazine (25 mg for first 3 patients, then escalate to 50 mg if no DLT) daily starting 7 days prior to radiation start. Interim Phase: Continue oral chlorpromazine daily dose post-radiation and prior to beginning adjuvant temozolomide. Adjuvant Phase: 28 days after radiation fini (+/- 5 business days), Start oral temozolomide (starting dose 150 mg/m2/day and escalated to 200 mg/m2/day if no treatment related adverse events noted) once daily for 5 consecutive days of a 28 day cycle, and continue oral daily chlorpromazine seven days a week per cycle. The adjuvant phase treatment will continue for up to 6 cycles. Cycle length is 28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chlorpromazine
2010
Completed Phase 4
~930
Temozolomide
2010
Completed Phase 3
~1930
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

Varun Monga, MDLead Sponsor
6 Previous Clinical Trials
126 Total Patients Enrolled
1 Trials studying Glioblastoma
Mohammed MilhemLead Sponsor
6 Previous Clinical Trials
134 Total Patients Enrolled
Mohammed Milhem, MBBSPrincipal InvestigatorUniversity of Iowa Hospitals and Clinics Holden Comprehensive Cancer Center
4 Previous Clinical Trials
90 Total Patients Enrolled

Media Library

Chlorpromazine (Phenothiazine Antipsychotic) Clinical Trial Eligibility Overview. Trial Name: NCT05190315 — Phase 1
Glioblastoma Research Study Groups: Chlorpromazine with standard of care chemoradiation
Glioblastoma Clinical Trial 2023: Chlorpromazine Highlights & Side Effects. Trial Name: NCT05190315 — Phase 1
Chlorpromazine (Phenothiazine Antipsychotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05190315 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have volunteered for this research project?

"Affirmative. Clinicaltrials.gov data reveals that this trial, which was originally posted on 28th January 2022, is currently recruiting individuals for participation. A total of 15 people are needed from 1 clinical site."

Answered by AI

Is recruitment for this research still open?

"Affirmative. According to the information on clinicialtrials.gov, this study is currently attempting to recruit 15 individuals from a single site. This clinical trial was first made available on 28th of January and last updated 1st March 2022."

Answered by AI

Are there any potential risks associated with Chlorpromazine?

"Our team at Power assessed the safety of chlorpromazine with a score of 1, as this is an early-phase trial and there are limited studies supporting its efficacy or security."

Answered by AI

Are there any other documented investigations involving Chlorpromazine?

"At present, there are 207 research initiatives for Chlorpromazine currently in operation. 24 of these live clinical trials have reached Phase 3 status. Most of the studies pertaining to this drug take place in Seoul and Songpa; however, 4753 medical centres across the world offer it as well."

Answered by AI

Has there been a precedent for this sort of research endeavor?

"Since 2002, Chlorpromazine has been the subject of numerous clinical trials; the first was sponsored by Schering-Plough and involved 60 participants. After this initial trial concluded, Phase 2 drug approval for chlorpromazine was granted. Nowadays, 207 active studies are being conducted in 36 countries across 935 cities."

Answered by AI

What medical issues does Chlorpromazine typically address?

"Chlorpromazine is most commonly administered to manage nausea. It has also been successful at treating progression, disease, advance directives and refractory neuroblastoma."

Answered by AI

What have researchers proposed as the expected outcome of this experiment?

"The primary goal of this 4-week clinical trial is to measure the safety and acute toxicity levels of chlorpromazine (CPZ) when administered as part of a standard treatment for glioblastoma multiforme (GBM), with grading based on NCI's Common Terminology Criteria for Adverse Events v 5.0 (CTCAE v5.0). The secondary objectives encompass establishing progression free survival 6 months post surgery, determining 2 year overall survival after completion of treatment, and assessing the efficacy of CPZ in regards to extending life expectancy beyond two years following therapy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Chlorpromazine and Standard of Care in Glioblastoma
Mohammed Milhem 2022. "Chlorpromazine and Standard of Care in Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05190315.
~1 spots leftby Jul 2024
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