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Anti-thyroid drug
Methimazole for Brain Tumor
Phase 2
Recruiting
Led By David Peereboom, MD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months after treatment
Awards & highlights
Study Summary
This trial is testing a drug, Methimazole, to see if it can safely treat brain tumors. It will be given to study participants in increasing doses until side effects occur.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects of Methimazole may include allergic reactions similar to other drugs in its class; however, specifics for brain tumors aren't known since it's usually used for thyroid issues. Side effects could become clearer as different doses are tested.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months after treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months after treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival (PFS) Rate
Trial Design
1Treatment groups
Experimental Treatment
Group I: Surgical Resection, Pharmacodynamic Assays, and MethimazoleExperimental Treatment3 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methimazole
2006
Completed Phase 4
~710
Find a Location
Who is running the clinical trial?
Case Comprehensive Cancer CenterLead Sponsor
452 Previous Clinical Trials
31,891 Total Patients Enrolled
David Peereboom, MDPrincipal InvestigatorCleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
9 Previous Clinical Trials
384 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I do not have any uncontrolled illnesses that could affect my participation.I am 18 years old or older.My brain tumor is a grade 4 glioma and surgery to remove it is planned.I have a history of thyroid problems.My doctor thinks I should have chemotherapy after surgery.I don't have any other cancers that could affect this treatment's safety or results.My hepatitis B virus load is undetectable with treatment.I cannot or do not want to swallow pills.I have not taken methimazole for my condition.I am HIV positive with undetectable viral load, on stable HAART, and don't need preventive antibiotics or antifungals.I do not have chronic diarrhea or conditions like Crohn's disease.My side effects from previous treatments are mild, except for hair loss and nerve issues.My blood counts and organ functions are within the required ranges for the study.I am not pregnant or will use birth control during the study.I have waited the required time after my last cancer treatment before joining this trial.
Research Study Groups:
This trial has the following groups:- Group 1: Surgical Resection, Pharmacodynamic Assays, and Methimazole
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there opportunities for interested parties to join this research initiative?
"According to clinicaltrials.gov, this medical experiment is actively searching for volunteers. The trial was initially listed on March 1st 2023 and has since been revised as of the 9th of that same month."
Answered by AI
How many volunteers are currently enrolled in this medical experiment?
"Affirmative, the clinicaltrials.gov website mentions that this project is currently seeking participants. This research was initially published on March 1st 2023 and has been revised as recently as September 3rd of the same year. 19 people are required to join at one single site."
Answered by AI
How perilous is it for people to undergo Surgical Resection, Pharmacodynamic Assays, and Methimazole?
"As this is a Phase 2 trial and there are only data confirming the safety of Surgical Resection, Pharmacodynamic Assays, and Methimazole, it received an assessment score of 2."
Answered by AI
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