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Monoclonal Antibodies
Cetuximab + Bevacizumab for Brain Tumor
Phase 1 & 2
Recruiting
Led By Heather McCrea, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if monthly infusions of cetuximab and bevacizumab can safely and effectively treat young people with brain tumors.
Who is the study for?
This trial is for patients under 22 with specific brain tumors that have come back or didn't respond to treatment. They need normal blood counts, liver and kidney function, and can't have had chemotherapy in the last three weeks. They must be able to perform daily activities at a certain level and not planning major surgery soon.
What is being tested?
The study tests monthly doses of cetuximab and bevacizumab delivered directly into the artery leading to the brain tumor in young patients. It aims to see how safe this method is and how well it works against aggressive brain tumors.
What are the potential side effects?
Cetuximab may cause skin reactions, low magnesium levels, infusion reactions, while bevacizumab might lead to high blood pressure, bleeding issues, poor wound healing, blood clots or heart problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Composite Overall Response Rate (CORR)
Number of Treatment Related Adverse Events
Overall Survival (OS)
+1 moreAwards & 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: SIACI of cetuximab and bevacizumabExperimental Treatment1 Intervention
Participants in this group will receive Cetuximab and Bevacizumab infusion into an artery each month for up to approximately one year.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
University of MiamiLead Sponsor
949 Previous Clinical Trials
428,437 Total Patients Enrolled
Heather McCrea, MDPrincipal InvestigatorUniversity of Miami
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a confirmed diagnosis of a specific type of brain tumor.I do not have any major health or mental conditions that would make treatment risky for me.I haven't had chemotherapy in the last three weeks.I am on a stable or decreasing dose of steroids for my brain tumor.I am not pregnant or breastfeeding.I haven't taken growth factor treatments in the last week.I had a craniotomy more than 2 weeks ago, or it's been 4 weeks since my last Avastin therapy if I had any major surgery planned.I can care for myself but may need occasional help.My blood tests show enough neutrophils and platelets.
Research Study Groups:
This trial has the following groups:- Group 1: SIACI of cetuximab and bevacizumab
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.
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