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)

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
New York
Stony Brook University Hospital
RECRUITING
Stony Brook
Contact Information
Primary
Sumbul Yousafi, MS
sumbul.yousafi@stonybrookmedicine.edu
631-508-2212
Backup
Alexander Stessin, MD
alexander.stessin@stonybrookmedicine.edu
631-638-1000
Time Frame
Start Date: 2022-10-25
Estimated Completion Date: 2029-08
Participants
Target number of participants: 12
Treatments
Experimental: Treatment
Sponsors
Collaborators: Genentech, Inc.
Leads: Stony Brook University

This content was sourced from clinicaltrials.gov

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