Study on Methimazole for Patients with Progressive Glioblastoma
Sponsor: Case Comprehensive Cancer Center
ClinicalTrials ID:NCT05607407
This clinical trial is testing the safety and effectiveness of Methimazole, a drug usually used for thyroid issues, in treating glioblastoma, a type of brain tumor. The study will explore different doses to find the safest and most effective one.
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Program Overview
The purpose of this study is to see if Methimazole, a drug not yet approved for brain tumors, can help treat glioblastoma. Participants will receive different doses of Methimazole to find the safest and most effective dose. The study will involve blood tests, physical exams, MRI scans, and taking the study drug.
Description
Researchers are exploring a new way to treat glioblastoma, a type of brain cancer, by using a drug called Methimazole. This drug is typically used for thyroid problems but may help increase a substance in the body called hydrogen sulfide (H2S), which could slow down the growth of glioblastoma. In past studies, increasing H2S levels has shown promise in treating this cancer. The study will test if Methimazole can safely boost H2S levels and improve treatment outcomes for glioblastoma patients. Participants will take Methimazole along with their standard cancer treatments to see if it helps extend their survival and control the disease.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of grade 4 glioma, a type of brain tumor, and plan to have surgery.
- Must not have used Methimazole for this condition before.
- Must be 18 years or older.
- Must be in good general health, with a performance status score of 70% or higher.
- Must have adequate organ function and meet specific blood test criteria.
- Must have normal thyroid function.
- Women of childbearing age must have a negative pregnancy test and agree to use birth control during the study.
- Must be able to swallow tablets.
- Must have waited a certain amount of time after previous treatments before starting the study.
- HIV-positive patients can participate if their viral load is undetectable and they are on stable treatment.
- Patients with hepatitis B or C must have controlled or cured infections.
- Must be eligible for chemotherapy after surgery.
- Must understand and agree to the study requirements and sign a consent form.
Exclusion Criteria
- Unresolved side effects from previous treatments, except for hair loss and nerve damage.
- Currently taking other experimental drugs.
- Allergic to Methimazole or similar drugs.
- Have uncontrolled health issues like infections, heart problems, or mental health conditions that could affect participation.
- Have another cancer that could interfere with the study.
- Have chronic digestive issues with diarrhea.
- Pregnant or breastfeeding.
- Have a history of thyroid problems.
- Unable or unwilling to swallow tablets.
- Have significant health issues that make participation inappropriate.
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