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Monoclonal Antibodies

Fractionated Stereotactic Radiation Therapy for Glioblastoma

Phase 2
Recruiting
Led By Stephen J Bagley
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing a combination of therapies to see if they're more effective than radiation therapy alone in treating recurrent glioblastoma.

Who is the study for?
This trial is for adults with recurrent glioblastoma, a type of brain cancer, who've had prior radiation therapy. They must have adequate organ function and not be pregnant or nursing. Participants need to agree to use contraception and can't have certain infections, autoimmune diseases, or recent treatments that could affect the immune system.Check my eligibility
What is being tested?
The study tests if adding tocilizumab (an antibody targeting inflammation) and atezolizumab (an immunotherapy drug) to fractionated stereotactic radiation therapy is more effective in treating recurrent glioblastoma than radiation alone.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system such as inflammation in various organs, infusion-related reactions like fever or chills, increased risk of infection due to immune suppression, and possible liver issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose-limiting toxicities (Safety Run-In)
Maximum-tolerated dose (Safety Run-In)
Objective radiographic response rate (Phase II, Non-Surgical Cohort)
Secondary outcome measures
Incidence of adverse events (Surgical Cohort and Non-Surgical Cohort)
Overall survival (Phase II, Non-Surgical Cohort)
Overall survival (Phase II, Surgical Cohort)
+2 more
Other outcome measures
Immune response (Phase II, Surgical Cohort)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Group II, Arm II (tocilizumab, atezolizumab, FSRT, surgery)Experimental Treatment6 Interventions
Patients receive systemic treatment with atezolizumab IV over 30-60 minutes on day 1. Within 3-7 days, patients undergo FSRT for 3-5 fractions over 3-5 days. Within 7-14 days after FSRT, patients undergo surgery. Within 21-24 days from the first dose of systemic treatment, patients resume treatment with tocilizumab IV over 60 minutes with or without atezolizumab. Treatment repeats every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo MRI and tumor tissue collection on study. Patients undergo MRI throughout the trial, as well as blood sample and tumor tissue collection on study.
Group II: Group II, Arm I (tocilizumab, atezolizumab, FSRT, surgery)Experimental Treatment6 Interventions
Patients receive systemic treatment with tocilizumab IV over 60 minutes with or without atezolizumab IV over 30-60 minutes on day 1. Within 3-7 days, patients undergo FSRT for 3 fractions over 3-5 days. Within 7-14 days after FSRT, patients undergo surgery. Within 21-24 days from the first dose of systemic treatment, patients resume treatment with tocilizumab with or without atezolizumab. Treatment repeats every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo MRI throughout the trial, as well as blood sample and tumor tissue collection on study.
Group III: Group I (tocilizumab, atezolizumab, FSRT)Experimental Treatment4 Interventions
Patients receive systemic treatment with tocilizumab IV over 60 minutes with or without atezolizumab IV over 30-60 minutes on day 1. Within 3-7 days, patients undergo FSRT for 3 fractions over 3-5 days in the absence of disease progression or unacceptable toxicity. Starting 4 weeks from the first dose of systemic treatment, patients resume treatment with tocilizumab with or without atezolizumab. Treatment repeats every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo MRI throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1700
Conventional Surgery
2006
Completed Phase 3
~1080
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Tocilizumab
2012
Completed Phase 4
~1840
Atezolizumab
2017
Completed Phase 3
~5860

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,665 Previous Clinical Trials
40,925,801 Total Patients Enrolled
322 Trials studying Glioblastoma
23,062 Patients Enrolled for Glioblastoma
NRG OncologyOTHER
231 Previous Clinical Trials
100,799 Total Patients Enrolled
13 Trials studying Glioblastoma
4,075 Patients Enrolled for Glioblastoma
Stephen J BagleyPrincipal InvestigatorNRG Oncology

Frequently Asked Questions

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

Has the FDA sanctioned Fractionated Stereotactic Radiation Therapy?

"Our team at Power assigned Fractionated Stereotactic Radiation Therapy a safety rating of 2, as clinical data exists to support its security but no evidence has been found demonstrating the therapy's efficacy."

Answered by AI

Are several healthcare facilities carrying out this experiment in the vicinity?

"The research team is recruiting patients from multiple sites, including the Kaiser Permanente Los Angeles Medical Center in Los Angeles, California, Ascension Via Christi Hospitals Wichita in Wichita, Kansas and Geisinger Cancer Services-Pottsville in Pottsville, Pennsylvania. Additionally there are 66 other enrolment locations available."

Answered by AI

What other investigations have studied the efficacy of Fractionated Stereotactic Radiation Therapy?

"In 2008, the Fractionated Stereotactic Radiation Therapy (FSRT) was first researched at SCRI Tennesee Oncology Chattanooga. To this day, 311 studies have been successfully completed and 411 trials are actively in progress with a high concentration of these experiments being done in Los Angeles, California."

Answered by AI

What is the ultimate goal of this research endeavor?

"This clinical trial will span up to 1 post-FRST cycle of systemic therapy, with the objective radiographic response rate being measured as a primary outcome. Adverse events experienced by patients in both cohorts will be documented and graded according to Common Terminology Criteria for Adverse Events version 5.0 while progression-free survival (PFS) across all arms are estimated using Kaplan-Meier method."

Answered by AI

Is this the pioneering study of its kind?

"Ever since its initial trial in 2008, sponsored by Hoffmann-La Roche and involving 720 patients, Fractionated Stereotactic Radiation Therapy has been subject of research. After the Phase 2 drug approval was granted following this first study, 411 trials are currently live worldwide across 81 nations and 1797 cities."

Answered by AI

What is the maximum number of participants eligible for this research study?

"Affirmative. Clinicaltrials.gov has information regarding this study which is currently recruiting patients; the original posting date was July 6th 2021 and it was most recently updated on November 23rd 2022 with a requirement for 12 volunteers across 68 medical sites."

Answered by AI

Is this trial currently open to new participants?

"Affirmative. According to the research posted on clinicaltrials.gov, this study is actively looking for participants and was initially published on July 6th 2021. It has since been updated last November 23rd 2022 and aims to recruit 12 individuals from 68 different sites."

Answered by AI

What diseases does Fractionated Stereotactic Radiation Therapy typically target?

"Fractionated Stereotactic Radiation Therapy is mainly used to treat small cell lung cancer (sclc), but has also been found efficacious in treating systemic juvenile idiopathic arthritis (sjia) and malignant neoplasms, as well as cytokine release syndrome caused by car-t cell therapy."

Answered by AI

Who else is applying?

What site did they apply to?
California Pacific Medical Center-Pacific Campus
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Testing the Addition of the Immune Therapy Drugs, Tocilizumab and Atezolizumab, to Radiation Therapy for Recurrent Glioblastoma
2022. "Testing the Addition of the Immune Therapy Drugs, Tocilizumab and Atezolizumab, to Radiation Therapy for Recurrent Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04729959.
All > Glioblastoma Long Beach
~18 spots leftby Jun 2025
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