Temozolomide + Dexbrompheniramine for Brain Tumor
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to: 1) evaluate the safety, tolerability, and recommended dose of dexbrompheniramine when combined with metronomic temozolomide for adults with recurrent high-grade glioma who have been previously treated with standard of care chemoradiation therapy and 2) determine the efficacy of the combination therapy in adults with glioblastoma who progressed during the first six cycles of adjuvant standard dose temozolomide.
The main questions it aims to answer are:
* What medical problems to participants have when taking dexbrompheniramine together with temozolomide?
* What is the correct dose of dexbrompheniramine to use when evaluating the safety and efficacy of the combination therapy?
* Is the combination therapy more effective at delaying disease progression compared to temozolomide alone?
Participants will take dexbrompheniramine and temozolomide every day at night.
Who Is on the Research Team?
Nicole A Shonka, MD
Principal Investigator
University of Nebraska
Are You a Good Fit for This Trial?
This trial is for adults with high-grade brain tumors (like glioblastoma or gliosarcoma) that have come back after standard treatment, including chemoradiation. Participants must have previously received temozolomide and now need further therapy.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Dexbrompheniramine
- Temozolomide
Trial Overview
The study tests a daily combination of dexbrompheniramine and low-dose (metronomic) temozolomide to find the safest dose and see if it works better than temozolomide alone in slowing tumor growth.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants receive daily dexbrompheniramine at the recommended phase 2 dose together with 50mg/m2/day temozolomide for up to one year or until progression or intolerance.
Participants receive daily dexbrompheniramine (either 4 mg, 6 mg, or 8 mg) together with 50mg/m2/day temozolomide for up to one year or until progression or intolerance.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Nebraska
Lead Sponsor
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