Methimazole in Patients With Progressive Glioblastoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCase Comprehensive Cancer Center

About 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.

Eligibility criteria

Qualifiers

Subjects must have histologically or cytologically confirmed WHO grade 4 glioma (including tumors with molecularly defined grade 4 astrocytoma) for which a clinically indicated tumor resection is planned.

Subjects must not have received methimazole for this disease.

Age is greater than or equal to 18 years of age

Performance status: Karnofsky Performance status ≥ 70%

Disqualifiers

Prior treatment toxicities not resolved to ≤ Grade 1 according to NCI CTCAE Version 5.0 except alopecia and neuropathy.

Subjects receiving any other investigational agents.

History of allergic reactions attributed to compounds of similar chemical or biologic composition to methimazole.

Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Trial design

Treatments tested in this trial

  • Methimazole
  • Recurrent Glioblastoma Surgical Resection
  • Pharmacodynamic Assays

Treatment groups

19 Participants
are divided into 1 treatment group

Locations

1
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center44195, ClevelandOhio, United States

Sponsors and collaborators

Case Comprehensive Cancer Center

Lead sponsor