Atezolizumab and Pre-Surgical Brain Radiation Therapy for Glioblastoma Multiforme

Part of paid clinical trials in Stony Brook, New York.

Sponsor
Stony Brook University
Study ID
NCT05423210
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Glioblastoma Multiforme

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 25, 2022
Status verified
Dec 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2029

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment

Primary Outcome Measure

Number of participants who progress/relapse after surgical resection [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stony Brook University HospitalStony BrookNew York11794
Alexander M Stessin, MD
[email protected]
631-444-2200
Caterina Vacchi-Suzzi, PhD
[email protected]
631-216-2993

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By research site
Stony Brook University Hospital· Stony Brook, NY

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