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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT06492954
Phase
PHASE1
Status
Recruiting
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Conditions

  • Osteosarcoma
  • Pulmonary Recurrence of Osteosarcoma

Eligibility Criteria

Sex
ALL
Age
N/A - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Surgical Resection — PROCEDURE
    Removal of all lung nodules, including the radiated nodule, per the standard of care for osteosarcoma patients with lung metastasis.
  • Stereotactic Body Radiation Therapy (SBRT) — RADIATION
    Dose level 1: 8 Gy\* 3 (Total 24 Gy) Dose level 2: 18 Gy\* 3 (Total 54 Gy)
  • Atezolizumab — DRUG
    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

Study Details

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

Key Dates

Start date
Jul 31, 2026
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose escalation
    Unilateral: Participants start with atezolizumab, followed ≤ 1 week later by SBRT at the assigned dose for a single lesion. After 2 cycles, those with unilateral disease undergo complete surgical resection, including all lung nodules, including the radiated one, as per osteosarcoma standard care. Atezolizumab resumes 14-28 days post-op, per protocol criteria, barring toxicity or disease progression. Bilateral: Subjects first undergo surgery on the non-SBRT side. 7-14 days later, they start atezolizumab, followed ≤ 1 week later by SBRT on the other lesion. After 2 cycles of atezolizumab, surgery on the contralateral side removes all lung nodules, including the radiated one, per standard care. Atezolizumab resumes 14-18 days post-op, per protocol criteria, barring toxicity or disease progression

Primary Outcome Measure

Number of participants with Dose limiting toxicity at Dose Level 1 [ Time Frame: Baseline, end of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Chilldren's Healthcare of AtlantaAtlantaGeorgia30322
Thomas Cash, MD, MSc
[email protected]
404-785-0910
Thomas Cash, MD, MSc (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By research site
Chilldren's Healthcare of Atlanta· Atlanta, GA

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