Atezolizumab and Pre-Surgical Brain Radiation Therapy for Glioblastoma Multiforme
ConditionGlioblastoma Multiforme
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorStony Brook University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patient already underwent surgical total or partial tumor resection, or radiation therapy
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
Trial design
Design model
Single group
Treatments tested in this trial
Atezolizumab + FSRT radiation
Combination productAtezolizumab 840mg IV every 2 weeks Fractionated Stereotactic Radiotherapy
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
2 years2
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
Time frame
30 days after the last dose of atezolizumabSponsors and contacts
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Stony Brook University
Lead sponsor
Genentech, Inc.
Collaborator
Source ClinicalTrials.gov