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Atezolizumab and Pre-Surgical Brain Radiation Therapy for Glioblastoma Multiforme

Sponsor
Stony Brook University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05423210
Collaborator
Genentech, Inc. (Industry)
12
Enrollment
1
Arm
47
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Atezolizumab + FSRT radiation
 Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
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)
Anticipated Study Start Date :
Aug 31, 2022
Anticipated Primary Completion Date :
Aug 1, 2026
Anticipated Study Completion Date :
Aug 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment

Combination Product: Atezolizumab + FSRT radiation
Atezolizumab 840mg IV every 2 weeks Fractionated Stereotactic Radiotherapy

Outcome Measures

Primary Outcome Measures

  1. Number of participants who progress/relapse after surgical resection [2 years]

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

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [30 days after the last dose of atezolizumab]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Stony Brook University
  • Genentech, Inc.

Investigators

  • Principal Investigator: Alexander Stessin, MD, Stony Brook Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alexander Stessin, Professor of Medicine, Stony Brook University
ClinicalTrials.gov Identifier:
NCT05423210
Other Study ID Numbers:
  • SBU-FSRT-NEURO
First Posted:
Jun 21, 2022
Last Update Posted:
Jun 21, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Glioblastoma
Atezolizumab

Study Results

No Results Posted as of Jun 21, 2022