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Proton Beam Therapy
Proton Therapy + Avastin for Recurrent Glioblastoma
N/A
Recruiting
Led By Eric Mellon, MD, PhD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have recurrent glioblastoma or variants such as gliosarcoma based on specified criteria
Age at least 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing a new way to find and treat brain cancer using MRI scans and proton therapy. The hope is that this will kill more cancer cells with less side effects.
Who is the study for?
Adults with recurrent glioblastoma who've had prior brain radiation, can undergo MRI scans, and have a life expectancy of over 12 weeks. They must not be pregnant or breastfeeding and agree to use contraception. Excluded are those with multi-focal disease across multiple lobes, previous Bevacizumab treatment, certain unstable health conditions, or recent major surgeries.Check my eligibility
What is being tested?
The trial tests an experimental MRI technique (sMRI) to better target proton radiotherapy for recurrent glioblastoma. It also evaluates the safety and effectiveness of adding Bevacizumab (Avastin) to minimize side effects from this intensified treatment approach.See study design
What are the potential side effects?
Potential side effects include risks associated with proton therapy such as skin redness and soreness at the treatment site, fatigue, headaches, hair loss near treated areas; Bevacizumab may cause high blood pressure, bleeding issues, wound healing complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition is recurrent glioblastoma or a similar type.
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I am 18 years old or older.
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I can care for myself but may not be able to do active work.
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My diagnosis is glioblastoma according to the latest standards.
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I am not pregnant or I am confirmed to be menopausal.
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I have had brain radiation therapy for glioma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Grade 3 irreversible or any Grade 4/5 neurologic toxicity.
Percentage of patients for whom sMRI-guided therapy is technically successful
Secondary outcome measures
Comparison of Apparent Diffusion Coefficients (ADC) among MRI techniques
Comparison of Cerebral Blood Volumes (CBV) among MRI techniques
Health-Related Quality of Life (HRQOL) Scores: FACT-Br Questionnaire
+3 moreSide effects data
From 2015 Phase 4 trial • 45 Patients • NCT0203642422%
vitreous hemorrhage
17%
worsening of cataract
9%
posterior capsule opacification
9%
vitreous syneresis
4%
cranial nerve VI palsy
4%
bradycardia
4%
pneumonia
4%
pyelonephritis
4%
colon cancer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab
Ozurdex
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort B: sMRI-Guided RT at 40 Gy in 10 fractionsExperimental Treatment2 Interventions
Participants will receive a total dose of 4000 cGY (40Gy) of Spectroscopic Magnetic Resonance Imaging (sMRI)-guided radiation therapy delivered in 10 fractions, 400 cGy (4 Gy) to the Clinical Target Volume (CTV) by Intensity Modulated Proton Therapy (IMPT) simultaneous integrated boost technique.
Participants will also receive Bevacizumab per standard of care, at treating physician's discretion. Initial dose will begin prior to first dose of radiation therapy (RT).
Group II: Cohort A: sMRI-Guided RT at 35 Gy in 10 fractionsExperimental Treatment2 Interventions
Participants will receive a total dose of 3500 centigrays (cGY) (35Gy) of Spectroscopic Magnetic Resonance Imaging (sMRI)-guided radiation therapy delivered in 10 fractions, 350 cGy (3.5 Gy) to the Clinical Target Volume (CTV) by Intensity Modulated Proton Therapy (IMPT) simultaneous integrated boost technique.
Participants will also receive Bevacizumab per standard of care, at treating physician's discretion. Initial dose will begin prior to first dose of radiation therapy (RT).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
Find a Location
Who is running the clinical trial?
University of MiamiLead Sponsor
902 Previous Clinical Trials
409,920 Total Patients Enrolled
4 Trials studying Glioblastoma
77 Patients Enrolled for Glioblastoma
Eric Mellon, MD, PhDPrincipal InvestigatorUniversity of Miami
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant and willing to use contraception if of childbearing potential.My glioma has not been treated with standard first-line therapies.I have had a severe hypertension crisis or brain issues due to high blood pressure.My glioma has been treated with radiation therapy twice.My condition is recurrent glioblastoma or a similar type.I have had an allergic reaction to Bevacizumab before.I finished brain radiation treatment at least 4-6 months ago.I am 18 years old or older.I am on full-dose anticoagulants and meet the specific requirements.I can care for myself but may not be able to do active work.I have not had a non-healing wound, ulcer, or bone fracture in the last 90 days.I have been cancer-free for at least 1 year from any previous cancer.My glioblastoma has returned in specific parts of my brain.I have waited the required time since my last cancer treatment.My diagnosis is glioblastoma according to the latest standards.I have not had any bleeding events, including gastrointestinal, in the last 30 days.I have not had major surgery or a serious injury in the last 28 days.I agree to use effective birth control.My brain tumor is not classified as glioblastoma.I am not pregnant or I am confirmed to be menopausal.I will be taking chemotherapy alongside the study treatment, but not bevacizumab.My cancer is present in multiple locations.I have been treated with Bevacizumab before.I have had brain radiation therapy for glioma.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A: sMRI-Guided RT at 35 Gy in 10 fractions
- Group 2: Cohort B: sMRI-Guided RT at 40 Gy in 10 fractions
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being recruited to participate in this experiment?
"Correct. According to clinicaltrials.gov, this medical study is actively seeking participants; the trial was initially posted on September 30th 2022 and was last modified on the same day. The investigation requires 96 patients from 1 site."
Answered by AI
What is the overall aim of this research project?
"Initially, the primary outcome of this experiment will be graded according to Grade 3 irreversible or any Grade 4/5 neurologic toxicity over a period of 60 days. Secondary goals involve ascertaining Overall Survival (OS), Progression-Free Survival (PFS) and comparing Cerebral Blood Volumes (CBV) between Spectroscopic MRI, conventional MRI and multiparametric MRI. OS is calculated from radiation therapy commencement until death, whilst PFS involves noting down progression or mortality without consideration for survival time; censoring occurs when the patient's last contact was made.. CBV evaluates volume of blood in brain tissue per 100g using millilit"
Answered by AI
Are there still openings to participate in this experiment?
"Clinicaltrials.gov attests that this clinical trial is still accepting patients, with the first posting occuring on September 30th 2022 and a subsequent update also occurring on that same date."
Answered by AI
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