Glioblastoma Multiforme
Conditions
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 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.
Interventions
COMBINATION_PRODUCTAtezolizumab + FSRT radiation
Atezolizumab 840mg IV every 2 weeks Fractionated Stereotactic Radiotherapy
Sponsors
Genentech, Inc.
Stony Brook University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who progress/relapse after surgical resection | 2 years | Assess the efficacy of atezolizumab in combination with fractionated stereotactic radiation therapy in the neoadjuvant setting for resectable glioblastoma multiforme |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | 30 days after the last dose of atezolizumab | Assess the safety of atezolizumab in combination with fractionated stereotactic radiation therapy in the neoadjuvant setting for resectable glioblastoma multiforme |
Countries
United States
Contacts
Primary ContactSumbul Yousafi, MS
Backup ContactAlexander Stessin, MD
Outcome results
None listed