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Anti-angiogenic agent

PRDR + Bevacizumab for Brain Tumor

Phase 2

Recruiting

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

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

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall survival

Secondary outcome measures

Change in Karnofsky Performance Status

Change in Mini Mental State Exam (MMSE) Score

Change in Participant Reported FACIT-F Score

+4 more

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 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor

1,189 Previous Clinical Trials

3,169,466 Total Patients Enrolled

Genentech, Inc.Industry Sponsor

1,541 Previous Clinical Trials

568,063 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,925,774 Total Patients Enrolled

Media Library

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

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

Brain Tumor Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT01743950 — Phase 2

Bevacizumab (Anti-angiogenic agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01743950 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it dangerous for patients with brain cancer to take Bevacizumab?

"While Phase 2 trials don't usually have data supporting efficacy, this particular trial for Bevacizumab-exposed patients with recurrent IDH mutant glioma does have evidence suggesting it is safe."

Answered by AI

Are there any similar cases to the Bevacizumab-exposed with recurrent IDH mutant glioma?

"As of now, there are a total of 375 clinical trials being conducted for patients with Bevacizumab-exposed recurrent IDH mutant glioma. Out of those active studies, 99 have reached Phase 3. Most of the many trials for Bevacizumab-exposed with recurrent IDH mutant glioma originated in Taibei, Taiwan; however, there are 18908 locations running these types of tests worldwide."

Answered by AI

What illnesses does Bevacizumab-exposed with recurrent IDH mutant glioma typically help to alleviate?

"Bevacizumab-exposed with recurrent IDH mutant glioma is commonly used to treat malignant neoplasms. Bevacizumab-exposed with recurrent IDH mutant glioma can also be effective at treating various other conditions including recurrent platinum sensitive primary peritoneal cancer, stage iv epithelial ovarian cancer following initial surgical resection, and locally advanced nonsquamous non-small cell lung cancer."

Answered by AI

Are there any more places open for people who want to participate in this research?

"The clinical trial is recruiting participants right now, as seen on clinicaltrials.gov. This information was first posted on December 3rd 2012 and updated November 14th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase II Study of Pulse Reduced Dose Rate Radiation Therapy With Bevacizumab

2012. "A Phase II Study of Pulse Reduced Dose Rate Radiation Therapy With Bevacizumab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01743950.

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