Actively Recruiting
Methimazole in Patients With Progressive Glioblastoma
Led by Case Comprehensive Cancer Center · Updated on 2026-03-04
19
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Methimazole in Patients With Progressive Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed WHO grade 4 glioma or molecularly defined grade 4 astrocytoma with planned tumor resection
- No prior treatment with methimazole for this disease
- Age 18 years or older
- Karnofsky Performance status of 70% or higher
- Adequate organ function and laboratory values within 21 days before study entry: Hemoglobin 8 g/dl, Absolute neutrophil count 1,200/mcL, Platelet count 75,000/mcL, Total bilirubin < 1.5 times institutional upper limit of normal (ULN), AST 3 times ULN, ALT 3 times ULN, Creatinine clearance > 50 mL/min, PT/INR < 1.4 if not on warfarin
- For patients on full-dose anticoagulants: no active bleeding or high-risk bleeding condition and stable INR between 2 and 3
- Normal thyroid function within 21 days before study entry (less than or equal to 3 times ULN)
- Women of childbearing potential must have a negative pregnancy test within 21 days before study entry
- Women and men of reproductive potential must agree to use adequate contraception during and up to 30 days after treatment
- Ability to swallow whole tablets
- Minimum intervals from prior treatments: at least 4 weeks since surgery, 6 weeks since nitrosoureas, standard intervals since last cytotoxic chemotherapy dose as specified, 2 weeks since investigational or non-cytotoxic therapy, and 4 weeks since bevacizumab
- HIV-positive patients allowed if undetectable viral load within 6 months, stable HAART regimen, and no need for antibiotics or antifungals for infections
- Patients with chronic hepatitis B must have undetectable viral load on suppressive therapy if indicated
- Patients with hepatitis C must be cured or have undetectable viral load if on treatment
- Candidate for post-operative chemotherapy
- Ability and willingness to provide informed consent
You will not qualify if you...
- Unresolved prior treatment toxicities greater than Grade 1 except alopecia and neuropathy
- Receiving any other investigational agents
- History of allergic reactions to methimazole or similar compounds
- Uncontrolled illnesses such as active infections, symptomatic heart failure, unstable angina, arrhythmias, or psychiatric/social conditions limiting study compliance
- Other prior or concurrent malignancies that may interfere with safety or efficacy assessment, except those with no impact
- Significant chronic gastrointestinal disorders with diarrhea as a major symptom or Grade 2 or higher diarrhea of any cause at screening
- Pregnant or breastfeeding
- Known history of hyperthyroidism or hypothyroidism
- Inability or unwillingness to swallow tablets
- Significant medical, laboratory, or psychiatric conditions making the patient unsuitable for the study as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
D
David Peereboom, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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