Phase 1b Trial of Atezolizumab in Combination With Stereotactic Body Radiation Therapy (SBRT) and Surgery in Patients With Pulmonary Recurrence of Osteosarcoma
Emory University
Summary
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
Description
The overall survival at 5 years after recurrence of OS ranges from 16% to 23% in most studies, highlighting the need for novel treatment approaches. Aggressive surgical resection is the standard of care for resectable osteosarcoma recurrences limited to the lung. While previous studies testing immune checkpoint inhibitors (ICIs) in osteosarcoma have shown limited efficacy, preclinical osteosarcoma studies demonstrate improved outcomes when ICIs are combined with radiation and administered with minimal residual disease. The proposed research will be a single-arm, safety pilot evaluating the saf…
Eligibility
- Age range
- Up to 50 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
Interventions
- ProcedureSurgical Resection
Removal of all lung nodules, including the radiated nodule, per the standard of care for osteosarcoma patients with lung metastasis.
- RadiationStereotactic Body Radiation Therapy (SBRT)
Dose level 1: 8 Gy\* 3 (Total 24 Gy) Dose level 2: 18 Gy\* 3 (Total 54 Gy)
- DrugAtezolizumab
For subjects \<18 years of age at the time of enrollment, Atezolizumab will be administered IV on Day 1 of each 21-day cycle at a dose of 15 mg/kg (maximum dose of 1200 mg). Subjects ≥ 18 years old will receive a flat dose of 1200 mg IV on Day 1 of each 21-day cycle
Location
- Chilldren's Healthcare of AtlantaAtlanta, Georgia