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NCT05423210 | RECRUITING | Glioblastoma Multiforme

Atezolizumab and Pre-Surgical Brain Radiation Therapy for Glioblastoma Multiforme
Sponsor:

Stony Brook University

Information provided by (Responsible Party):

Alexander Stessin

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

Glioblastoma Multiforme

Intervention/treatment

Atezolizumab + FSRT radiation

Phase

EARLY_PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 12 participants
Masking : NONE
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)
Actual Study Start Date : 2022-10-25
Estimated Primary Completion Date : 2027-08
Estimated Study Completion Date : 2029-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Atezolizumab and Pre-Surgical Brain Radiation Therapy for Glioblastoma Multiforme

Location Details

NCT05423210

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Locations

RECRUITING

United States, New York

Stony Brook University Hospital

Stony Brook, New York, United States, 11794