Atezolizumab with Radiation and Surgery for Relapsed Osteosarcoma
This study is testing a new approach for people with osteosarcoma that has returned in the lungs. It combines a drug called Atezolizumab (a checkpoint inhibitor, which helps your immune system fight cancer) with Stereotactic Body Radiation Therapy (SBRT), a focused type of radiation, and surgery to remove lung tumors. The main goal is to see how safe this combination treatment is and how well people tolerate it. You might be able to join if you are up to 50 years old, have osteosarcoma that has come back only in your lungs, and all your lung tumors can be surgically removed. This study is currently unclear on its recruitment status and plans to enroll 12 participants.
- Study design
- This is a single-arm study, meaning all participants receive the same treatment, and it aims to enroll 12 people. The phase of the study is not specified.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for dose-limiting toxicities at baseline and at the end of one year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06492954
Atezolizumab in Combination With Stereotactic Body Radiation Therapy (SBRT) and Surgery for Relapsed Osteosarcoma
Recruiting
PHASE1Up to 50InterventionalTreatmentEmory UniversityInvestigator-initiated
~12 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:Surgical ResectionStereotactic Body Radiation Therapy (SBRT)Atezolizumab
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with Dose limiting toxicity at Dose Level 1
Measured over Baseline, end of 1 year
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesGeorgia1
Study leadership
- Thomas Cash, MD, MSc · PRINCIPAL_INVESTIGATOR · Emory University
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
Participants must have at least 1 lesion that is ≥ 5 mm and meets the criteria to receive SBRT AND an additional nodule(s) that meets protocol definition for a metastatic nodule necessitating surgical resection: single nodule ≥ 5 mm, or ≥ 2 nodules ≥ 3 mm in size
Patients must have a Lansky (≤ 16 years) or Karnofsky (\> 16 years) score of ≥ 60, or ECOG performance score of ≤ 2
All prior treatment-related toxicities must have resolved to ≤ Grade 1 OR be determined clinically stable by the treating investigator.
Adequate Bone Marrow Function Defined: Peripheral absolute neutrophil count (ANC) ≥ 750/mm3, Platelet count ≥ 50,000/mm3. Must be transfusion independent defined as not receiving platelet transfusions for at least 7 days before enrollment
Adequate Renal Function Defined As Creatinine clearance or radioisotope ≥ GFR 70ml/min/1.73 m2
Adequate Liver Function Defined As Total bilirubin ≤ 1.5 x the upper limit of normal (ULN) for age, ALT (SGPT) ≤ 3 x the ULN. For this study, the ULN for ALT (SGPT) is 45 U/L.
Adequate Pancreatic Function Defined As Serum lipase ≤ 1.5 x ULN
Adequate Thyroid Function Defined As Normal free T4
Adequate Pulmonary Function Defined As No dyspnea at rest, Pulse oximetry \> 92% on room air
Adequate Cardiac Function Defined As QTc ≤ 480 msec, Shortening fraction ≥ 27% by echocardiogram or ejection fraction ≥ 50% by gated radionuclide study or echocardiogram
Urine protein: Meets one of the following criteria: (1) urinary protein by urine dipstick is ≤ 100 mg/dL or ≤ 2+; OR (2) Urine Protein Creatinine (UPC) ratio \< 3.5; OR (3) if 24-hour urine protein was measured, urinary protein ≤ 3500 mg.
Life expectancy of at least 4 months.
Negative urine or serum pregnancy test in women of childbearing potential.
Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation. Patients should maintain adequate contraception for at least 5 months after the last dose of atezolizumab. Adequate contraception is defined as abstinence or use of contraceptives with a failure rate of \< 1% per year.
All participants and their parents or legal guardians must sign a written informed consent and assent (if applicable).
Exclusion
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
Active autoimmune disorder that has required systemic treatment in the past 12 months, or a documented history of severe autoimmune disorder, or a syndrome that requires systemic steroids or immunosuppressive agents. Participants with type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement, or skin disorders such as vitiligo, psoriasis, or alopecia not requiring systemic treatment may be permitted to enroll.
Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months before initiation of study treatment, unstable arrhythmia, or unstable angina.
Prior treatment with an immune checkpoint inhibitor is allowed provided it was not permanently discontinued due to toxicity and was not given with radiation.
Active tuberculosis
Any medical condition or illness that would compromise the participants's ability to undergo surgery, cause unacceptable safety risk, or compromise compliance with the protocol.
Chronic use of immunosuppressive therapies.
Participants with an uncontrolled infection.
Subjects who have received prior allogeneic stem cell transplant or solid organ transplant are not eligible.
Participants who, in the opinion of the investigator, may not be able to comply with the protocol-required procedures.
Participants who are currently receiving any other investigational or anti-cancer agents.
Participants with a known history of HIV, hepatitis B, and/or hepatitis C (testing not required as part of screening).
Current or prior pneumonitis.
Live/attenuated vaccine administered within 30 days of enrollment
What this trial measures
- Number of participants with Dose limiting toxicity at Dose Level 1Baseline, end of 1 year
If 6 participants have been enrolled and evaluated, and only 0 or 1 have experienced a DLT, the next participant will be enrolled at Dose Level 2
- Number of participants with Dose limiting toxicity at Dose Level 2Baseline, end of 1 year
If 6 participants have been enrolled and evaluated, and only 0 or 1 have experienced a DLT, enrollment will be terminated, and accrual determined complete.