Combining Atezolizumab with radiation therapy for brain tumors
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)
This study is testing if combining a cancer drug called Atezolizumab with radiation therapy can help people with newly diagnosed brain tumors feel better and improve their treatment results.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stony Brook University Academic / other |
| Drugs / interventions | radiation, Atezolizumab |
| Locations | 1 site (Stony Brook, New York) |
| Trial ID | NCT05423210 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with newly diagnosed glioblastoma multiforme who are surgical candidates and can tolerate the treatment regimen.
Not a fit: Patients with multifocal disease, leptomeningeal disease, or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance treatment efficacy and improve survival rates for patients with glioblastoma multiforme.
How similar studies have performed: While combining immunotherapy with radiation is a growing area of interest, this specific combination has not been extensively tested in glioblastoma, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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:
* 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 this trial is running
Stony Brook, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.