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NCT04729959 · ClinicalTrials.gov registry record · Phase 2
Testing the Addition of the Immune Therapy Drugs, Tocilizumab and Atezolizumab, to Radiation Therapy for Recurrent Glioblastoma
A Phase 2 study of Recurrent Glioblastoma and Diffuse Astrocytoma, IDH-Wildtype, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 59
- Enrollment target
- 20
- Study locations
NCT04729959: Active Phase 2 study of Recurrent Glioblastoma and Diffuse Astrocytoma, IDH-Wildtype, sponsored by National Cancer Institute (NCI).
NCT04729959 is a Phase 2 study of Recurrent Glioblastoma and Diffuse Astrocytoma, IDH-Wildtype that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 59 participants, below the 68-participant average among 62 other Recurrent Glioblastoma trials with a reported enrollment target (13% lower). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04729959, a Phase 2 study of Recurrent Glioblastoma and Diffuse Astrocytoma, IDH-Wildtype, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 59 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies the best dose and effect of tocilizumab in combination with atezolizumab and stereotactic radiation therapy in treating glioblastoma patients whose tumor has come back after initial treatment (recurrent). Tocilizumab is a monoclonal antibody that binds to receptors for a protein called interleukin-6 (IL-6), which is made by white blood cells and other cells in the body as well as certain types of cancer. This may help lower the body's immune response and reduce inflammation. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Fractionated stereotactic radiation therapy uses special equipment to precisely deliver multiple, smaller doses of radiation spread over several treatment sessions to the tumor. The goal of this study is to change a tumor that is unresponsive to cancer therapy into a more responsive one. Therapy with fractionated stereotactic radiotherapy in combination with tocilizumab may suppress the inhibitory effect of immune cells surrounding the tumor and consequently allow an immunotherapy treatment by atezolizumab to activate the immune response against the tumor. Combination therapy with tocilizumab, atezolizumab and fractionated stereotactic radiation therapy may shrink or stabilize the cancer better than radiation therapy alone in patients with recurrent glioblastoma.
Primary Outcome
The maximum tolerated dose (MTD) was defined as the highest prespecified dose level with an observed dose-limiting toxicity (DLT) rate of ≤33% of participants. MTD was determined during the safety run-in by testing increasing prespecified dose levels of tocilizumab alone and in combination with atezolizumab in Arms 1-3, with cohorts of 3 to 6 participants enrolled at each dose level. Dose escalation began with tocilizumab 4 mg/kg (Dose Level 1 / Arm 1), followed by tocilizumab 8 mg/kg (Dose Leve
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- BIOLOGICAL Atezolizumab
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Conventional Surgery
- RADIATION Fractionated Stereotactic Radiation Therapy
Study Locations (20)
California
- Kaiser Permanente-Anaheim - Anaheim
- Kaiser Permanente-Bellflower - Bellflower
- Kaiser Permanente Los Angeles Medical Center - Los Angeles
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- Kaiser Permanente-Ontario - Ontario
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- Sutter Cancer Centers Radiation Oncology Services-Roseville - Roseville
- Sutter Roseville Medical Center - Roseville
- Sutter Medical Center Sacramento - Sacramento
- University of California Davis Comprehensive Cancer Center - Sacramento
- Kaiser Permanente-San Diego Zion - San Diego
- California Pacific Medical Center-Pacific Campus - San Francisco
Colorado
- UCHealth University of Colorado Hospital - Aurora
- UCHealth Memorial Hospital Central - Colorado Springs
- Memorial Hospital North - Colorado Springs
- Poudre Valley Hospital - Fort Collins
- Cancer Care and Hematology-Fort Collins - Fort Collins
- UCHealth Greeley Hospital - Greeley
- Medical Center of the Rockies - Loveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2022-03-11 |
| Est. Completion | 2026-09-04 |
| Phase | Phase 2 |
What the registry record for NCT04729959 still lists
NCT04729959 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 68-participant average among 62 other Recurrent Glioblastoma trials with a reported enrollment target (13% lower).
The record links to 2 conditions, with Recurrent Glioblastoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04729959 names 20 study sites across 2 states, led by California, Colorado.
Frequently Asked Questions
What is clinical trial NCT04729959 about?
NCT04729959 is a clinical study titled "Testing the Addition of the Immune Therapy Drugs, Tocilizumab and Atezolizumab, to Radiation Therapy for Recurrent Glioblastoma". This phase II trial studies the best dose and effect of tocilizumab in combination with atezolizumab and stereotactic radiation therapy in treating glioblastoma patients whose tumor has come back after initial treatment (recurrent). Tocilizumab is a monoclonal antibody that binds to receptors for a ...
What is the current status of trial NCT04729959?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2022-03-11. Estimated completion is 2026-09-04.
What conditions does trial NCT04729959 study?
This clinical trial studies the following conditions: Recurrent Glioblastoma, Diffuse Astrocytoma, IDH-Wildtype.
What interventions are being tested in trial NCT04729959?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Atezolizumab (BIOLOGICAL), Magnetic Resonance Imaging (PROCEDURE), Conventional Surgery (PROCEDURE), Fractionated Stereotactic Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT04729959?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04729959 being conducted?
This trial has 20 study locations across California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04729959's enrollment target sits among peer trials
59 21st of 62 higher than 42 of 62 other Recurrent Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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