Status:
RECRUITING
Atezolizumab and Pre-Surgical Brain Radiation Therapy for Glioblastoma Multiforme
Lead Sponsor:
Stony Brook University
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- Diagnosis of glioblastoma multiforme WHO Grade IV
- The patient is a surgical candidate, with the surgical intent for a \> 80% resection of the lesion
- Negative pregnancy test
- ECOG status \<= 2
- Tumor volume \<= 3.5 cm
- Adequate organ function
- Negative for infectious disease (human immunodeficiency virus, Hepatitis B Virus, Hepatitis C Virus, tubercolosis)
Exclusion
- Patient already underwent surgical total or partial tumor resection, or radiation therapy
- Presence of leptomeningeal disease, gliomatosis cerebri, multifocal disease, bilateral cerebral hemisphere involvement ("butterfly" gliomas)
- Patients at increased risk of neurologic decompensation
- Continued use of high dose intravenous or oral corticosteroids, or \> 8milligrams per day of systemic dexamethasone
- Uncontrolled tumor-related pain
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
- Uncontrolled or symptomatic hypercalcemia
- History of autoimmune disease or immune deficiency
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
- Significant cardiovascular disease
- History of other malignancy within 1 year prior to screening
- Severe infection within 4 weeks prior to initiation of study treatment
- History of allogeneic stem cell or organ transplant
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies
- Treatment with systemic immunostimulatory agents
- Treatment with systemic immunosuppressive medication
Key Trial Info
Start Date :
October 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2029
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05423210
Start Date
October 25 2022
End Date
August 1 2029
Last Update
December 22 2025
Active Locations (1)
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1
Stony Brook University Hospital
Stony Brook, New York, United States, 11794