RecruitingPhase 2NCT05607407

Methimazole in Patients With Progressive Glioblastoma

Targeting Transsulfuration Via Suppression of Thyroid Hormone Signaling in Progressive Glioblastoma: Phase 2 and Pharmacodynamic Trial of Methimazole in Patients With Progressive Glioblastoma

Sponsor

Case Comprehensive Cancer Center

Enrollment

19 participants

Start Date

Jan 30, 2023

Study Type

INTERVENTIONAL

Conditions

Glioblastoma Glioma

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a drug called methimazole — normally used to treat an overactive thyroid — can help treat glioblastoma, a very aggressive brain tumor (grade 4). It is for patients who are already scheduled to have surgery to remove their brain tumor. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with a WHO grade 4 brain tumor (glioblastoma or grade 4 astrocytoma) confirmed by biopsy - You are scheduled for a medically indicated brain tumor resection surgery - You have never been treated with methimazole for this condition - Your overall health and blood counts are adequate (Karnofsky score ≥ 70) **You may NOT be eligible if...** - You have already taken methimazole for this tumor - Your organ function (blood, liver, kidneys) does not meet required thresholds - You have other serious health conditions that may interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMethimazole

Starting dose: Methimazole 15 mg/d. Six participants will receive this dose. If they achieve a 10% increase in peripheral blood H2S concentrations, an additional 13 participants will receive this dose to accrue a total of 19 participants for which a preliminary estimate of PFS6 can be calculated. If the first 6 participants do not achieve a 10% increase in peripheral blood H2S concentrations, the dose will be increased to the second and final dose level of 25 mg/d at which 19 participants will be treated.

PROCEDURERecurrent Glioblastoma Surgical Resection

The purpose of resection is to remove as much tumor as possible to alleviate mass effect and to obtain brain tissue for experimental analysis.

DIAGNOSTIC_TESTPharmacodynamic Assays

Pharmacodynamic assays are intended to investigate drug and downstream drug-induced effects.

Locations(1)

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

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NCT05607407

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