Atezolizumab and Pre-Surgical Brain Radiation Therapy for Glioblastoma Multiforme

Glioblastoma Multiforme Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05423210
• Other study ID #: SBU-FSRT-NEURO
• Status: Recruiting
• Phase: Early Phase 1
• Start date: October 25, 2022
• Est. completion date: August 2026

Study information

• Verified date: February 2024
• Source: Stony Brook University
• Contact: Catherine Izzo, MS
• Phone: 631-372-7212
• Email: catherine.izzo[@]stonybrookmedicine.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• 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

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

Combination Product:
• Atezolizumab + FSRT radiation
Atezolizumab 840mg IV every 2 weeks Fractionated Stereotactic Radiotherapy

Locations

Country	Name	City	State
United States	Stony Brook University Hospital	Stony Brook	New York

Sponsors (2)

Lead Sponsor	Collaborator
Stony Brook University	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who progress/relapse after surgical resection	Assess the efficacy of atezolizumab in combination with fractionated stereotactic radiation therapy in the neoadjuvant setting for resectable glioblastoma multiforme	2 years
Primary	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	Assess the safety of atezolizumab in combination with fractionated stereotactic radiation therapy in the neoadjuvant setting for resectable glioblastoma multiforme	30 days after the last dose of atezolizumab