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Atezolizumab and Pre-Surgical Brain Radiation Therapy for Glioblastoma Multiforme

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05423210
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Early Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Stony Brook University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Alexander Stessin, MD
Principal Investigator Affiliation Stony Brook Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma Multiforme
Arms & Interventions

Arms

Experimental: Treatment

Interventions

Combination Product: - Atezolizumab + FSRT radiation

Atezolizumab 840mg IV every 2 weeks Fractionated Stereotactic Radiotherapy

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Stony Brook University Hospital, Stony Brook, New York

Status

Recruiting

Address

Stony Brook University Hospital

Stony Brook, New York, 11794

Site Contact

Alexander M Stessin, MD

alexander.stessin@stonybrookmedicine.edu

631-444-2200

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