PRDR + Bevacizumab for Brain Tumor

Overseen By Diana Trask, BS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Wisconsin, Madison

Must be taking: Bevacizumab

Disqualifiers: Pregnant, Uncontrolled hypertension, Prior malignancy, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

49 Participants Needed

Trial Summary

What is the purpose of this trial?

To determine the efficacy of Pulse Reduced Dose Rate (PRDR) radiation when given in 27 fraction over 5.5 weeks with concurrent bevacizumab followed by adjuvant bevacizumab until time of progression in patients with recurrent high grade gliomas (grade III and grade IV). Patients will be placed in 1 of 4 groups based on their histologic diagnosis and prior exposure to bevacizumab.

Research Team

Steve Howard, MD

Principal Investigator

University of Wisconsin, Madison

H. Ian Robins, MD, Ph.D

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

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.

Inclusion Criteria

Hematology, chemistry and a urinalysis must meet protocol specified criteria

I have had radiation and temozolomide for my brain tumor.

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

Exclusion Criteria

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

I had cancer before but was treated over a year ago and have been cancer-free since.

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

Treatment Details

Interventions

• Bevacizumab
• PRDR

Trial Overview 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.

Participant Groups

Group I: Bevacizumab-naïve with recurrent IDH mutant glioma Active Control 2 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 glioma Active Control 2 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 glioma Active Control 2 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 glioma Active Control 2 Interventions

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

Bevacizumab is already approved in European Union, United States, Japan, Canada for the following indications:

Approved in European Union as Avastin for:

• Colorectal cancer
• Breast cancer
• Non-small cell lung cancer
• Renal cell carcinoma
• Ovarian cancer

Approved in United States as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Glioblastoma
• Renal cell carcinoma
• Cervical cancer
• Ovarian cancer

Approved in Japan as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Breast cancer
• Renal cell carcinoma
• Ovarian cancer

Approved in Canada as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Breast cancer
• Renal cell carcinoma
• Ovarian cancer

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Genentech, Inc.

Industry Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+