Metronomic Temozolomide With Dexbrompheniramine for Recurrent High-Grade Glioma/Glioblastoma

Part of paid clinical trials in Omaha, Nebraska.

Sponsor: University of Nebraska
Study ID: NCT07859059
Phase: PHASE1/PHASE2
Status: Not Yet Recruiting

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Conditions

Glioblastoma
Gliosarcoma
High Grade Glioma

Eligibility Criteria

Sex: ALL
Age: 19 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Dexbrompheniramine — DRUG
Antihistamine, HRH1 antagonist
Temozolomide — DRUG
DNA Alkylating Agent

Study Details

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.

Key Dates

First listed: Oct 5, 2026
Start date: Jun 1, 2027
Status verified: Sep 2026
Primary completion: Jun 1, 2030
Completion: Jun 1, 2031

Study Design

Enrollment: 41 participants (estimated)
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: Arm I: Dose Finding
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.
Experimental: Arm II: 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.