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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

Must not have

Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception

Glioma that has not previously undergone standard first line therapies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant and willing to use contraception if of childbearing potential.

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My glioma has not been treated with standard first-line therapies.

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I have had a severe hypertension crisis or brain issues due to high blood pressure.

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My glioma has been treated with radiation therapy twice.

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I have had an allergic reaction to Bevacizumab before.

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My glioblastoma has returned in specific parts of my brain.

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I have not had major surgery or a serious injury in the last 28 days.

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My brain tumor is not classified as glioblastoma.

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I will be taking chemotherapy alongside the study treatment, but not bevacizumab.

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My cancer is present in multiple locations.

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I have been treated with Bevacizumab before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Grade 3 irreversible or any Grade 4/5 neurologic toxicity.

Percentage of patients for whom sMRI-guided therapy is technically successful

Secondary study objectives

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 more

Side effects data

From 2015 Phase 4 trial • 45 Patients • NCT02036424

22%

vitreous hemorrhage

17%

worsening of cataract

vitreous syneresis

posterior capsule opacification

cranial nerve VI palsy

pneumonia

pyelonephritis

colon cancer

bradycardia

100%

80%

60%

40%

20%

Study treatment Arm

Bevacizumab

Ozurdex

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~5540

0 / 17Eligibility criteria met