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Atezolizumab and Pre-Surgical Brain Radiation Therapy for Glioblastoma Multiforme

Primary Purpose

Glioblastoma Multiforme

Status

Active

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Atezolizumab + FSRT radiation

About this trial

This is an interventional treatment trial for Glioblastoma Multiforme

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Stony Brook University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Outcomes

Primary Outcome Measures

Number of participants who progress/relapse after surgical resection

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

Assess the safety of atezolizumab in combination with fractionated stereotactic radiation therapy in the neoadjuvant setting for resectable glioblastoma multiforme

Secondary Outcome Measures

Full Information

NCT ID

NCT05423210

First Posted

June 14, 2022

Last Updated

October 16, 2023

Sponsor

Stony Brook University

Collaborators

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05423210

Brief Title

Atezolizumab and Pre-Surgical Brain Radiation Therapy for Glioblastoma Multiforme

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)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 21, 2022 (Actual)

Primary Completion Date

August 2026 (Anticipated)

Study Completion Date

August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stony Brook University

Collaborators

Genentech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioblastoma Multiforme

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Intervention Type

Combination Product

Intervention Name(s)

Atezolizumab + FSRT radiation

Intervention Description

Atezolizumab 840mg IV every 2 weeks Fractionated Stereotactic Radiotherapy

Primary Outcome Measure Information:

Title

Number of participants who progress/relapse after surgical resection

Description

Assess the efficacy of atezolizumab in combination with fractionated stereotactic radiation therapy in the neoadjuvant setting for resectable glioblastoma multiforme

Time Frame

2 years

Title

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Description

Assess the safety of atezolizumab in combination with fractionated stereotactic radiation therapy in the neoadjuvant setting for resectable glioblastoma multiforme

Time Frame

30 days after the last dose of atezolizumab

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexander Stessin, MD

Organizational Affiliation

Stony Brook Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stony Brook University Hospital

City

Stony Brook

State/Province

New York

ZIP/Postal Code

11794

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Atezolizumab and Pre-Surgical Brain Radiation Therapy for Glioblastoma Multiforme

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