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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Methimazole
DrugStarting 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.
Recurrent Glioblastoma Surgical Resection
Procedure/SurgeryThe purpose of resection is to remove as much tumor as possible to alleviate mass effect and to obtain brain tissue for experimental analysis.
Pharmacodynamic Assays
Diagnostic testPharmacodynamic assays are intended to investigate drug and downstream drug-induced effects.
Treatment groups
19 Participants
are divided into 1 treatment groupGroup A: Surgical Resection, Pharmacodynamic Assays, and MethimazoleExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Progression Free Survival (PFS) Rate
defined as alive and free from progressive disease
Time frame
Up to 6 months after treatmentSponsors and contacts
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Source ClinicalTrials.gov