RecruitingEarly Phase 1NCT05423210

Atezolizumab and Pre-Surgical Brain Radiation Therapy for Glioblastoma Multiforme

A Pilot Study to Evaluate the Immunogenic Effects of Window-of-Opportunity Fractionated Stereotactic Radiotherapy Combined With Atezolizumab for Patients With Newly Diagnosed WHO CNS Grade 4 Glioma (Glioblastoma Multiforme)

Sponsor

Stony Brook University

Enrollment

12 participants

Start Date

Oct 25, 2022

Study Type

INTERVENTIONAL

Conditions

Glioblastoma Multiforme

Summary

This is a single-arm pilot study that will recruit 12 patients with newly diagnosed Glioblastoma, a malignant brain tumor with a poor prognosis. Patients will be treated with fractionated stereotactic radiotherapy (FSRT) for 2 weeks, in addition to two doses of Atezolizumab (Tecentriq), an FDA approved PD- L1 inhibitor drug, 840 mg IV, at the beginning and at the end of the two-week time period, concomitantly with FSRT. After this initial two weeks treatment the patients will undergo craniotomy and maximal safe resection as per normal care for a GB. After surgery patients will follow the normal care for glioblastoma in addition to Atezolizumab 840 mg IV q2 weeks for the duration of adjuvant treatment.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving atezolizumab (an immunotherapy drug) along with focused radiation to the brain tumor before surgery improves outcomes for patients with a newly diagnosed, high-grade brain tumor called glioblastoma multiforme (GBM). **You may be eligible if:** - You have been newly diagnosed with glioblastoma (WHO Grade IV brain tumor) - You are a candidate for surgery with the goal of removing more than 80% of the tumor - Your tumor is small enough (3.5 cm or less in diameter) - Your general health is adequate (ECOG 0–2) - You have adequate organ function - You test negative for HIV, hepatitis B, hepatitis C, and tuberculosis **You may NOT be eligible if:** - You have already had brain surgery or radiation for this tumor - Your tumor has spread to the lining of the brain, or is multifocal or involves both sides of the brain - You have an autoimmune disease or immune deficiency - You have a history of significant lung, heart, or other organ disease - You had another cancer within the past year - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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