Atezolizumab and Pre-Surgical Brain Radiation Therapy for Glioblastoma Multiforme

Launched by STONY BROOK UNIVERSITY · Jun 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to treat glioblastoma multiforme, a type of aggressive brain tumor. The trial will involve 12 patients who have recently been diagnosed with this condition. Participants will receive a combination of two weeks of targeted radiation therapy and a medication called Atezolizumab, which helps the body’s immune system fight cancer. After this initial treatment, patients will undergo surgery to remove as much of the tumor as possible. Following surgery, they will continue to receive Atezolizumab every two weeks as part of their ongoing treatment.

To be eligible for this trial, patients must have a confirmed diagnosis of glioblastoma and be suitable for surgery. They should also be in relatively good health, with no significant infections or other serious health issues. It’s important to note that this trial is currently recruiting participants, so if you or someone you know fits the eligibility criteria, you may consider discussing this opportunity with a healthcare provider. Overall, the trial aims to explore whether this combined treatment can improve outcomes for patients with this challenging condition.

Gender

ALL

Eligibility criteria

• 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