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

ConditionsOsteosarcomaPulmonary Recurrence of 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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • Surgical Resection

    Procedure/Surgery

    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

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Dose escalationExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Number of participants with Dose limiting toxicity at Dose Level 1

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

Time frame
Baseline, end of 1 year
2

Number of participants with Dose limiting toxicity at Dose Level 2

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.

Time frame
Baseline, end of 1 year

Secondary outcomes

1

Disease Control Rate

The DC rate is defined as the number of patients without disease progression during the first 12 months after enrollment.

Time frame
Baseline, at 12 months
2

Progression-free survival (PFS)

PFS is defined as the time from first dose of Atezolizumab to disease relapse, disease progression, or death from any cause

Time frame
Baseline, through study completion (an average of 1 year)
3

Overall Survival

Overall survival is defined as the time from first dose of Atezolizumab to death from any cause. Subjects who are alive at the time of analysis will be censored at the date of last follow-up

Time frame
Baseline, through study completion (an average of 1 year)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Emory University

Lead sponsor

Genentech, Inc.

Collaborator

Source ClinicalTrials.gov
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