Actively Recruiting

Phase 1
Age: 0 - 50Years
All Genders
NCT06492954

Atezolizumab in Combination With Stereotactic Body Radiation Therapy (SBRT) and Surgery for Relapsed Osteosarcoma

Led by Emory University · Updated on 2026-03-02

12

Participants Needed

1

Research Sites

65 weeks

Total Duration

On this page

Sponsors

E

Emory University

Lead Sponsor

G

Genentech, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Atezolizumab in Combination With Stereotactic Body Radiation Therapy (SBRT) and Surgery for Relapsed Osteosarcoma

Who Can Participate

Age: 0 - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologic verification of osteosarcoma at original diagnosis or relapse
  • In first or greater relapse of osteosarcoma
  • Lung-only recurrence (unilateral or bilateral)
  • All pulmonary nodules must be resectable without pneumonectomy
  • At least one lesion 5 mm suitable for SBRT plus additional nodules meeting surgical criteria
  • Lansky or Karnofsky score �b0 60, or ECOG performance score �b2 2
  • All prior treatment toxicities resolved to Grade �b1 or clinically stable
  • Specific waiting periods after prior treatments before enrollment
  • Adequate bone marrow, renal, liver, pancreatic, thyroid, pulmonary, and cardiac function
  • Urine protein within defined limits
  • Life expectancy of at least 4 months
  • Negative pregnancy test for women of childbearing potential
  • Use of effective contraception during study participation and for 5 months after last dose
  • Signed informed consent and assent if applicable
Not Eligible

You will not qualify if you...

  • Pregnancy or breast-feeding
  • Active metastatic disease outside lungs including bone, CNS, or other sites
  • Greater than Grade 1 pleural effusion
  • Prior lung radiation
  • Active or severe autoimmune disorders requiring systemic treatment recently or historically
  • Significant cardiovascular disease within 3 months before treatment
  • Active tuberculosis
  • Medical conditions risking surgery or protocol compliance
  • Chronic immunosuppressive therapy use
  • Uncontrolled infection
  • Prior allogeneic stem cell or solid organ transplant
  • Currently receiving other investigational or anti-cancer agents
  • Known HIV, hepatitis B, or hepatitis C infection
  • Current or prior pneumonitis
  • Live or attenuated vaccine within 30 days of enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Chilldren's Healthcare of Atlanta

Atlanta, Georgia, United States, 30322

Actively Recruiting

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Research Team

T

Thomas Cash, MD, MSc

CONTACT

C

Chloe Edgerton

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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Atezolizumab in Combination With Stereotactic Body Radiation Therapy (SBRT) and Surgery for Relapsed Osteosarcoma | DecenTrialz