RECRUITING

Atezolizumab and Pre-Surgical Brain Radiation Therapy for Glioblastoma Multiforme

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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)

Quick Facts

Study Start:2022-10-25

Study Completion:2026-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05423210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	* 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

Inclusion Criteria

Exclusion 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)

* 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

Contacts and Locations

Study Contact

Sumbul Yousafi, MS

CONTACT

631-508-2212

sumbul.yousafi@stonybrookmedicine.edu

Alexander Stessin, MD

CONTACT

631-638-1000

alexander.stessin@stonybrookmedicine.edu

Principal Investigator

Alexander Stessin, MD

PRINCIPAL_INVESTIGATOR

Stony Brook Cancer Center

Study Locations (Sites)

Stony Brook University Hospital

Stony Brook, New York, 11794

United States

Collaborators and Investigators

Sponsor: Stony Brook University

Alexander Stessin, MD, PRINCIPAL_INVESTIGATOR, Stony Brook Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-25

Study Completion Date2026-08

Study Record Updates

Study Start Date2022-10-25

Study Completion Date2026-08

Terms related to this study

Additional Relevant MeSH Terms

Glioblastoma Multiforme