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Radiation Therapy + Bevacizumab for Recurrent Brain Cancer

N/A

Waitlist Available

Led By Susan L McGovern

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must have received one and only one previous course of radiation to the brain, delivered at 1.5 - 2.5 Gy/fraction, one fraction per day

Lansky/Karnofsky performance status score of 50-100

Must not have

Patients with recurrent diffuse intrinsic pontine glioma (DIPG)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing different ways of giving radiation therapy to patients with brain tumors that have come back after previous treatment. The goal is to find the best way to give the therapy with the least amount of side effects.

Who is the study for?

This trial is for patients with brain tumors that have returned after previous radiation therapy. Eligible participants must have had only one prior round of radiation, may have undergone surgery before re-radiation, and should not be pregnant or have recurrent diffuse intrinsic pontine glioma (DIPG). They need a performance status score of 50-100 and recent imaging showing recurrent disease.

What is being tested?

The study tests the side effects and optimal dose of re-administering radiation therapy to treat recurring brain tumors. It explores whether different methods of delivering radiation can more effectively kill tumor cells. Bevacizumab may also be used at the treating neuro-oncologist's discretion.

What are the potential side effects?

Potential side effects include those typically associated with radiation therapy such as fatigue, skin irritation, hair loss in the treated area, headaches, nausea, and potential damage to surrounding healthy brain tissue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had one round of brain radiation at a specific dose.

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I can do most activities but may need help.

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My recent scans show signs of my brain disease coming back.

Exclusion Criteria

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

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My condition is recurrent DIPG.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3.5 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

Highest grade of central nervous system (CNS) necrosis

Secondary study objectives

Overall survival (OS) time

Progression-free survival (PFS) time

Quality of life

Other study objectives

Symptom burden

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

Active Control

Group I: Arm I (conventional fractionation)Experimental Treatment2 Interventions

Patients undergo radiation therapy with conventional fractionation and dose constraints. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (conventional fractionation, bevacizumab)Active Control3 Interventions

Patients undergo radiation therapy with conventional fractionation and dose constraints. Patients also receive bevacizumab concurrently at the discretion of the treating neuro-oncologist. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 4Eligibility criteria met