Combining Atezolizumab with radiation therapy for brain tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study aims to evaluate the safety and efficacy of combining Atezolizumab, an FDA-approved PD-L1 inhibitor, with fractionated stereotactic radiotherapy (FSRT) in patients with newly diagnosed glioblastoma multiforme. Twelve patients will receive FSRT over two weeks alongside two doses of Atezolizumab, followed by surgical resection of the tumor. Post-surgery, patients will continue receiving Atezolizumab as part of their standard care. The study focuses on assessing the potential benefits of this combination treatment in improving patient outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Stony Brook University Hospital
  Stony Brook, New York, United States Recruiting

Study contacts

• Principal investigator: Alexander Stessin, MD — Stony Brook Cancer Center
• Study coordinator: Sumbul Yousafi, MS
• Email: sumbul.yousafi@stonybrookmedicine.edu
• Phone: 631-508-2212

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.