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

No Placebo-Only Group

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months after treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression Free Survival (PFS) Rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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