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NCT05423210EARLY_PHASE1Recruiting

Atezolizumab and Pre-Surgical Brain Radiation Therapy for Glioblastoma Multiforme

Stony Brook University

Start Date

10/25/2022

Completion Date

8/1/2029

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 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 Criteria: * 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

Interventions

COMBINATION_PRODUCT

Atezolizumab + FSRT radiation

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Conditions

Glioblastoma Multiforme

Locations

Stony Brook University Hospital

Stony Brook, New York 11794

United States