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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).

Must not have

Prior radiation therapy to the head or neck, which would result in overlap of radiation therapy fields.

History of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or chlorpromazine.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had radiation therapy to my head or neck before.

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I am allergic to medications similar to temozolomide or chlorpromazine.

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I do not have major brain or nerve conditions like MS, Parkinson's, myasthenia gravis, or dementia.

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I do not have any severe illnesses or conditions that my current treatments can't control.

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I have had chemotherapy for my current brain tumor.

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My brain tumor has come back and is aggressive.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Extrapyramidal Disorder

Somnolence

Upper respiratory tract infection

Palpitations

Diarrhea

Hepatic Function Abnormal

Tachycardia

Heart rate increased

Nasopharyngitis

Orthostatic Hypotension

Akathisia

100%

80%

60%

40%

20%

Study treatment Arm

Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)

Chlorpromazine

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1880