Atezolizumab in Combination With Stereotactic Body Radiation Therapy (SBRT) and Surgery for Relapsed Osteosarcoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
AgeUp to 50
SponsorEmory University
About this trial
This study aims to determine the safety and tolerability of combined Atezolizumab, stereotactic body radiation therapy (SBRT), and surgical resection of pulmonary metastases in patients with pulmonary recurrence of osteosarcoma
Eligibility criteria
Qualifiers
Participants must have had histologic verification of osteosarcoma at the original diagnosis or relapse
Participants must be in first or greater relapse of osteosarcoma
Recurrence must be limited to the lung but can be unilateral or bilateral
All pulmonary nodules must be resectable as determined by the institutional surgeon. Resectable pulmonary nodules are defined as nodules that can be removed without performing a pneumonectomy (e.g., nodules immediately adjacent to the main stem bronchus or main pulmonary vessels). There is no maximum number of lesions provided the surgeon thinks a complete surgical remission can be achieved.
Disqualifiers
Pregnancy or Breast-Feeding
Active metastatic disease outside of the lungs including bone, CNS, or any extrapulmonary involvement
> Grade 1 pleural effusion
Prior lung radiation
Trial design
Treatments tested in this trial
- Surgical Resection
- Stereotactic Body Radiation Therapy (SBRT)
- Atezolizumab
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Emory University
Lead sponsor
Genentech, Inc.
Collaborator
Source ClinicalTrials.gov