Methimazole for Brain Tumor

Overseen By David Peereboom, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Case Comprehensive Cancer Center

Must not be taking: Investigational agents

Disqualifiers: Uncontrolled illness, Other malignancy, Hyperthyroidism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

19 Participants Needed

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

I am able to care for myself but may not be able to do active work.

I can swallow whole tablets.

I had hepatitis C but am cured, or I'm being treated with no detectable virus.

Exclusion Criteria

Subjects receiving any other investigational agents

I do not have any uncontrolled illnesses that could affect my participation.

Pregnant or breastfeeding

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Methimazole Administration

Participants receive oral methimazole for at least 5 days pre-operatively or until lower circulating thyroid hormone levels are achieved

1 week

1 visit (in-person)

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

4 weeks

Multiple visits for pharmacodynamic assays and MRI

Secondary Chemotherapy and Monitoring

Secondary chemotherapy may be added at the treating physician's discretion, with continued monitoring through PBPD assays and MRI

4 weeks

Multiple visits for pharmacodynamic assays and MRI

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 6 months

Treatment Details

Interventions

• Methimazole

Trial Overview The trial is testing Methimazole's safety and effectiveness in treating glioblastoma. Participants will receive varying doses of the drug before their surgery to see how well they tolerate it and if it helps control the tumor growth. The study includes regular health checks, MRI scans, and blood tests.

Participant Groups

Group I: Surgical Resection, Pharmacodynamic Assays, and Methimazole Experimental Treatment 3 Interventions

Participants with recurrent glioblastoma for whom surgical resection is indicated will have baseline peripheral blood pharmacodynamic assays (PBPD) followed by oral mehimazole at least 5 days pre-operatively or until lower circulating theyroid hormone levels are achieved. PBPD assays will then be repeated. After surgical resection, PBPD will be repeated a day later. When the participant is deemed able to begin methimazole (no sooner than 10 days post-op) PBPD assays will be repeated and the participant will begin methimazole for 4 weeks. At the end of the first 4 week cycle, an MRI will be performed. PBPD assays will be repeated after which secondary chemotherapy will be added at the treating physician's discretion. After 4 weeks, PBPD will be repeated and the participant will undergo another MRI at 8 weeks.

Methimazole is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Tapazole for:

• Hyperthyroidism

Approved in European Union as Thiamazole for:

• Hyperthyroidism
• Graves' disease
• Toxic multinodular goiter
• Thyrotoxic crisis

Approved in Canada as Thiamazole for:

• Hyperthyroidism

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+