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Monoclonal Antibodies

SIACI Bevacizumab + Temozolomide and Radiation for Glioblastoma

Phase 3

Recruiting

Led By John Boockvar, MD

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

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

Must have

Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control

Subject has a Karnofsky Performance Status (KPS) 70% or greater

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 62 months

Awards & highlights

Study Summary

This trial is testing whether a new treatment for brain cancer, which involves repeatedly injecting a drug directly into the brain, is more effective than the current standard of care.

Who is the study for?

This trial is for adults over 18 with newly diagnosed GBM brain cancer, expected to live at least 6 months. They must be able to have an MRI, use birth control if of reproductive potential, and sign consent. Participants need normal blood counts and organ function, a specific diagnosis of GBM per WHO criteria, and a Karnofsky Performance Status of 70% or higher.Check my eligibility

What is being tested?

The study compares two treatments for GBM: one group receives standard Temozolomide with Radiation; the other gets an additional treatment called SIACI Bevacizumab (Avastin) alongside Temozolomide and Radiation. The goal is to see if SIACI increases survival without disease progression or overall lifespan compared to the standard therapy.See study design

What are the potential side effects?

Potential side effects include complications from intraarterial infusion like stroke or bleeding in the brain, as well as those associated with Bevacizumab such as high blood pressure, bleeding problems, wound healing complications, kidney issues and immune reactions.

Eligibility Criteria

Inclusion Criteria

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

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I am not pregnant and agree to use birth control.

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I am mostly able to care for myself and carry out daily activities.

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My brain tumor is confirmed as GBM, IDH-wild type, according to 2021 WHO standards.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 62 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~62 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 62 months 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 (OS)

Secondary outcome measures

Progression-free survival (PFS)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SIACI of Bevacizumab (Avastin) with Temozolomide and RadiationExperimental Treatment1 Intervention

Repeated Superselective Intraarterial Cerebral infusion (SIACI) of Bevacizumab (Avastin) with Temozolomide and Radiation

Group II: Standard of care Temozolomide and RadiationActive Control1 Intervention

Standard of care Temozolomide and Radiation

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor

460 Previous Clinical Trials

470,611 Total Patients Enrolled

16 Trials studying Glioblastoma

441 Patients Enrolled for Glioblastoma

John Boockvar, MDPrincipal InvestigatorFeinstein Institute for Medical Research/Lenox Hill Hospital

13 Previous Clinical Trials

393 Total Patients Enrolled

11 Trials studying Glioblastoma

352 Patients Enrolled for Glioblastoma

Media Library

Bevacizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05271240 — Phase 3

Glioblastoma Research Study Groups: SIACI of Bevacizumab (Avastin) with Temozolomide and Radiation, Standard of care Temozolomide and Radiation

Glioblastoma Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT05271240 — Phase 3

Bevacizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05271240 — Phase 3

Glioblastoma Patient Testimony for trial: Trial Name: NCT05271240 — Phase 3

Frequently Asked Questions

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

Are investigators still looking for new participants for this experiment?

"This trial is still enrolling patients, with the most recent update having been on May 5th, 2022. The initial posting was on April 27th of the same year."

Answered by AI

How many individuals are included in this experiment?

"That is correct, the online information does state that the study is currently recruiting patients. The clinical trial was first posted on April 27th, 2022 and was last updated on May 5th, 2022. They are looking for a total of 432 individuals from 1 location."

Answered by AI

Is it legal to give patients Bevacizumab (Avastin), Temozolomide, and Radiation through Repeated Superselective Intraarterial Cerebral infusion (SIACI)?

"While this is only a Phase 3 trial, there is promising data from prior clinical studies and multiple rounds of safety testing. We rate the Repeated Superselective Intraarterial Cerebral infusion (SIACI) of Bevacizumab (Avastin) with Temozolomide and Radiation as a 3 on our Power scale."

Answered by AI

Who else is applying?

What state do they live in?

New York

What site did they apply to?

Lenox Hill Brain Tumor Center

What portion of applicants met pre-screening criteria?

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

On May 23, 2023, Dr. Jason Ellis performed a di-bulking craniotomy on me at Lennox Hill in NYC. I have a grade 4 Astrocytoma IDH Mutant. I trust Dr. Ellis and Dr. Boockvar; both Drs. have reviewed my medical condition.

PatientReceived 1 prior treatment

Recent research and studies

clinicaltrials.govStudy

Repeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab With Temozolomide and Radiation Compared to Temozolomide and Radiation Alone in Newly Diagnosed GBM

John Boockvar, MD Zucker SOM @Hofstra/Northwell 2022. "Repeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab With Temozolomide and Radiation Compared to Temozolomide and Radiation Alone in Newly Diagnosed GBM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05271240.

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