Study on Treating Relapsed or Hard-to-Treat Brain Tumors in Patients Under 22 Years Old
Sponsor: University of Miami
Sponsor score: 40
Inactive
ClinicalTrials ID:NCT05956821
This clinical trial is testing the safety and effectiveness of a monthly treatment using a special method to deliver the drugs cetuximab and bevacizumab directly to the brain in young patients with certain types of brain tumors.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate if a monthly treatment that delivers the drugs cetuximab and bevacizumab directly into the brain arteries is safe and effective for young patients under 22 years old with specific types of brain tumors that have returned or are difficult to treat.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of specific types of brain tumors, such as glioblastoma multiforme, anaplastic astrocytoma, or diffuse intrinsic brainstem glioma.
- Must have at least one tumor that can be measured and evaluated.
- Must have a performance status score of 60% or higher, indicating the ability to carry out daily activities.
- No chemotherapy for at least three weeks before starting the treatment.
- Must have enough healthy blood cells, with specific levels of neutrophils and platelets.
- Blood tests must show normal liver and kidney function.
- Blood clotting tests must be within normal limits.
- Must not have received growth factor treatments within one week before starting the study.
- If taking steroids for brain tumor symptoms, the dose must be stable or decreasing for at least one week before starting the study.
- Patients of reproductive age must agree to use effective birth control during and for three months after the study. A pregnancy test is required for females who can become pregnant.
- Patients or their guardians must understand and agree to the study by signing a consent form.
- Patients who have had brain surgery must wait at least two weeks before starting the treatment, and any major surgery after treatment should wait four weeks. Minor surgeries can be done after two weeks.
Exclusion Criteria
- Females who are pregnant or breastfeeding cannot participate.
- Participants must agree to use effective birth control during and for three months after the study. If they do not agree, they cannot join the study.
- Patients with serious medical or mental health conditions that could increase risks or affect their ability to follow the study requirements cannot participate.
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