Methimazole for Brain Tumor
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, there are specific time intervals required from prior treatments, and certain conditions must be met for patients on anticoagulants. It's best to discuss your current medications with the study team.
What is the purpose of this trial?
The purpose of this study is to test the effectiveness, safety, and tolerability of a drug called Methimazole. The investigational drug, Methimazole is not FDA approved for brain tumors, but it is used to treat thyroid illnesses. Different doses of Methimazole will be given to several study participants with glioblastoma. The first several study participants will receive the lowest dose. If the drug does not cause serious side effects, it will be given to other study participants at a higher dose. The doses will continue to increase for every group of study participants until the side effects occur that require the dose to be lowered. The procedures in this study are research blood draws, physical exams, collection of medical history, MRI scans, and study drug administration.
Research Team
David Peereboom, MD
Principal Investigator
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Eligibility Criteria
Adults with a specific brain tumor called glioblastoma, who are planning to have surgery for it, can join this trial. They need normal organ function and blood levels, no serious recent treatments or infections, and must be able to swallow pills. Pregnant women or those with certain medical conditions like heart failure or uncontrolled thyroid disease cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-operative Methimazole Administration
Participants receive oral methimazole for at least 5 days pre-operatively or until lower circulating thyroid hormone levels are achieved
Surgical Resection and Post-operative Methimazole
Participants undergo surgical resection, followed by methimazole administration starting no sooner than 10 days post-op for 4 weeks
Secondary Chemotherapy and Monitoring
Secondary chemotherapy may be added at the treating physician's discretion, with continued monitoring through PBPD assays and MRI
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Methimazole
Methimazole is already approved in United States, European Union, Canada for the following indications:
- Hyperthyroidism
- Hyperthyroidism
- Graves' disease
- Toxic multinodular goiter
- Thyrotoxic crisis
- Hyperthyroidism
Find a Clinic Near You
Who Is Running the Clinical Trial?
Case Comprehensive Cancer Center
Lead Sponsor