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Anti-angiogenic agent

PRDR + Bevacizumab for Brain Tumor

Phase 2

Waitlist Available

Led By Steve Howard, MD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

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

Must have

Recurrent disease based on combination of clinical, imaging or histologic confirmation

Must have previously received radiation and temozolomide to treat their glioma

Must not have

Uncontrolled hypertension (>160/90mmHg)

Active second malignancy unless non-melanoma skin cancer or cervical cancer in situ

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 3 months for bevacizumab exposed patients, at 6 and 12 months for all patients

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing a new radiation treatment for recurrent brain tumors, given over 5.5 weeks with a drug called bevacizumab. Patients will be followed for progression after treatment.

Who is the study for?

This trial is for adults over 18 with high-grade gliomas (Grade III or IV brain tumors) that have come back. They must not have used bevacizumab before, should be months past their initial radiation therapy and temozolomide treatment, and in a stable health condition as indicated by blood tests.

What is being tested?

The study is testing Pulse Reduced Dose Rate (PRDR) radiation given over 5.5 weeks with the drug bevacizumab, followed by more bevacizumab after radiation ends. Participants are divided into groups based on their tumor type and previous treatments.

What are the potential side effects?

Bevacizumab can cause headaches, high blood pressure, bleeding or nosebleeds, tiredness, wound healing problems, and could increase the risk of developing holes in your stomach or intestines.

Eligibility Criteria

Inclusion Criteria

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

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My disease has come back, confirmed by tests or scans.

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I have had radiation and temozolomide for my brain tumor.

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I finished my initial radiation therapy over 3 months ago after being treated with Bevacizumab.

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My brain tumor is a high-grade glioma, as confirmed by testing.

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I am over 18 and can do most daily activities by myself.

Exclusion Criteria

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

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My blood pressure is not higher than 160/90 mmHg.

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I have no active cancer except for non-melanoma skin cancer or cervical cancer in situ.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 3 months for bevacizumab exposed patients, at 6 and 12 months for all patients

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 3 months for bevacizumab exposed patients, at 6 and 12 months for all patients

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3 months for bevacizumab exposed patients, at 6 and 12 months for all patients for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Overall survival

Secondary study objectives

Change in Karnofsky Performance Status

Change in Mini Mental State Exam (MMSE) Score

Change in Participant Reported FACIT-F Score

+4 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

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

Trial Design

4Treatment groups

Active Control

Group I: Bevacizumab-naïve with recurrent IDH mutant gliomaActive Control2 Interventions

27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression

Group II: Bevacizumab-naïve with recurrent IDH wildtype high grade gliomaActive Control2 Interventions

27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression

Group III: Bevacizumab-exposed with refractory recurrent IDH wildtype high grade gliomaActive Control2 Interventions

27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression

Group IV: Bevacizumab-exposed with recurrent IDH mutant gliomaActive Control2 Interventions

27fractions over 5.5weeks of PRDR radiation with bevacizumab followed by adjuvant bevacizumab until time of progression

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor

1,234 Previous Clinical Trials

3,200,242 Total Patients Enrolled

Genentech, Inc.Industry Sponsor

1,564 Previous Clinical Trials

570,183 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,938 Previous Clinical Trials

41,023,139 Total Patients Enrolled

Steve Howard, MDPrincipal InvestigatorUniversity of Wisconsin, Madison

H. Ian Robins, MD, Ph.DPrincipal InvestigatorUniversity of Wisconsin, Madison

Media Library

Bevacizumab (Anti-angiogenic agent) Clinical Trial Eligibility Overview. Trial Name: NCT01743950 — Phase 2

$Brain Tumor Research Study Groups: Bevacizumab-naïve with recurrent IDH mutant glioma, Bevacizumab-naïve with recurrent IDH wildtype high grade glioma, Bevacizumab-exposed with refractory recurrent IDH wildtype high grade glioma, Bevacizumab-exposed with recurrent IDH mutant glioma$