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)
Stony Brook University
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- Combination ProductAtezolizumab + FSRT radiation
Atezolizumab 840mg IV every 2 weeks Fractionated Stereotactic Radiotherapy
Location
- Stony Brook University HospitalStony Brook, New York