Chlorpromazine and Standard of Care for Glioblastoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine whether adding chlorpromazine, an antipsychotic medication typically used for other conditions, can enhance the effectiveness of standard treatment for glioblastoma, an aggressive brain cancer. The standard treatment includes chemotherapy with temozolomide and radiation therapy. Participants will receive this combined treatment to assess its potential in better managing the disease. This trial may suit those recently diagnosed with glioblastoma who have already undergone surgery and are ready to begin treatment within five weeks. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to contribute to groundbreaking research.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, you cannot be on other investigational drugs or have uncontrolled illnesses, which might suggest some restrictions. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that chlorpromazine, a drug often used for mental health issues, might also help treat glioblastoma, a type of brain cancer. Studies have found that adding chlorpromazine to standard glioblastoma treatments is generally safe. The World Health Organization already considers it a safe drug.
In past research, patients handled chlorpromazine well when used with other cancer treatments. There were no major safety concerns, and using it with temozolomide, a common cancer drug, did not lead to unexpected side effects.
So far, evidence suggests that chlorpromazine is safe for glioblastoma when added to standard care. However, since this trial is in the early stages, safety is still being closely monitored.12345Why do researchers think this study treatment might be promising for glioblastoma?
Researchers are excited about using chlorpromazine in glioblastoma treatment because it introduces a new approach alongside the standard therapies of radiation and temozolomide. Chlorpromazine, traditionally used as an antipsychotic, is being explored for its potential anti-cancer properties, making it a novel addition to the glioblastoma treatment arsenal. Unlike conventional treatments that focus solely on targeting cancer cells with radiation and chemotherapy, chlorpromazine may disrupt cancer cell growth and survival through different mechanisms, potentially enhancing overall treatment efficacy. This combination could offer a more comprehensive attack on the tumor, which is why there's significant interest in its potential benefits.
What evidence suggests that chlorpromazine might be an effective treatment for glioblastoma?
Research has shown that chlorpromazine, a drug typically used for mental health conditions, might help treat glioblastoma, a type of brain cancer. It alters how cancer cells obtain energy, potentially stopping their growth. Specifically, it affects the Warburg effect, a process cancer cells use to grow. In this trial, participants will receive chlorpromazine alongside standard chemoradiation, which includes temozolomide, a common chemotherapy drug for glioblastoma. Studies suggest that chlorpromazine works well with temozolomide to weaken the tumor. This combination could reduce the cancer cells' ability to survive and help slow the disease. Early studies have shown promising results, but further research is needed to confirm these findings.23467
Who Is on the Research Team?
Mohammed Milhem, MBBS
Principal Investigator
University of Iowa Hospitals and Clinics Holden Comprehensive Cancer Center
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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
Continue oral chlorpromazine daily dose post-radiation and prior to beginning adjuvant temozolomide
Adjuvant Phase
Start oral temozolomide once daily for 5 consecutive days of a 28 day cycle, and continue oral daily chlorpromazine. Treatment will continue for up to 6 cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Chlorpromazine
- Radiation Therapy
- Temozolomide
Chlorpromazine is already approved in United States, European Union, Canada for the following indications:
- Schizophrenia
- Nausea and vomiting
- Hiccups
- Acute intermittent porphyria
- Tetanus
- Severe behavioral problems in children
- Schizophrenia and other psychoses
- Nausea and vomiting
- Hiccups
- Acute intermittent porphyria
- Tetanus
- Schizophrenia and other psychoses
- Nausea and vomiting
- Hiccups
- Acute intermittent porphyria
- Tetanus
Find a Clinic Near You
Who Is Running the Clinical Trial?
Varun Monga, MD
Lead Sponsor
Mohammed Milhem
Lead Sponsor