RecruitingEarly Phase 1NCT05423210

Atezolizumab and Pre-Surgical Brain Radiation Therapy for Glioblastoma Multiforme

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)

Sponsor

Stony Brook University

Enrollment

12 participants

Start Date

Oct 25, 2022

Study Type

INTERVENTIONAL

Conditions

Glioblastoma Multiforme

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

Min Age: 18 Years

Inclusion Criteria7

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 Criteria16

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