RecruitingNot ApplicableNCT05284643

Spectroscopic MRI, Proton Therapy, and Avastin for Recurrent Glioblastoma

Pilot Trial of Spectroscopic MRI-guided, Dose-Escalated Proton Radiation Therapy and Bevacizumab for Recurrent Glioblastoma


Sponsor

University of Miami

Enrollment

96 participants

Start Date

Sep 30, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this research is to find hidden cancer with an experimental magnetic resonance imaging (MRI) scan called spectroscopic magnetic resonance imaging (sMRI). That spectroscopic MRI scan will be used to increase the area of the brain receiving radiation and then the dose of radiation in attempt to kill more of the cancer. Proton radiotherapy and bevacizumab (Avastin) are used to minimize the possible side effects of this approach.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of proton radiation therapy and bevacizumab (a drug that cuts off blood supply to tumors) for people with glioblastoma — the most aggressive type of brain tumor — that has come back after initial treatment. A special MRI technique (spectroscopic MRI) is used to better target the radiation to active tumor areas. **You may be eligible if...** - You are 18 or older with glioblastoma that has come back after standard treatment (surgery and radiation) - The tumor area is 6 cm or smaller on MRI - You completed your initial brain radiation at least 4–6 months ago (depending on where the tumor is located) - Your overall health and organ function are adequate **You may NOT be eligible if...** - You have previously received bevacizumab - Your tumor has come back in multiple separate areas across different parts of the brain - You have had a heart attack, stroke, or serious infection recently - You are pregnant or breastfeeding - Your tumor is in certain deep brain regions that would cause imaging errors (brainstem, cerebellum, orbitofrontal cortex) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONIntensity Modulated Proton Therapy (IMPT)

Participants will receive radiation therapy delivered via intensity modulated proton therapy (IMPT) simultaneous integrated boost technique over a period of 10 days, 5 days per week for approximately 2 weeks.

DRUGBevacizumab

Bevacizumab will be administered intravenously (IV), beginning at a dose of 10 mg/kg every 2-3 weeks until disease progression.


Locations(1)

University of Miami

Miami, Florida, United States

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NCT05284643


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