Atezolizumab in Combination With Stereotactic Body Radiation Therapy (SBRT) and Surgery for Relapsed Osteosarcoma
- Conditions
- OsteosarcomaPulmonary Recurrence of Osteosarcoma
- Registration Number
- NCT06492954
- Lead Sponsor
- Emory University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria:<br><br> - Participants must have had histologic verification of osteosarcoma at the original<br> diagnosis or relapse<br><br> - Participants must be in first or greater relapse of osteosarcoma<br><br> - Recurrence must be limited to the lung but can be unilateral or bilateral<br><br> - All pulmonary nodules must be resectable as determined by the institutional surgeon.<br> Resectable pulmonary nodules are defined as nodules that can be removed without<br> performing a pneumonectomy (e.g., nodules immediately adjacent to the main stem<br> bronchus or main pulmonary vessels). There is no maximum number of lesions provided<br> the surgeon thinks a complete surgical remission can be achieved.<br><br> - Participants must have at least 1 lesion that is = 5 mm and meets the criteria to<br> receive SBRT AND an additional nodule(s) that meets protocol definition for a<br> metastatic nodule necessitating surgical resection: single nodule = 5 mm, or = 2<br> nodules = 3 mm in size<br><br> - Patients must have a Lansky (= 16 years) or Karnofsky (> 16 years) score of = 60, or<br> ECOG performance score of = 2<br><br> - All prior treatment-related toxicities must have resolved to = Grade 1 OR be<br> determined clinically stable by the treating investigator.<br><br> 1. Myelosuppressive chemotherapy: = 14 days after the last dose of<br> myelosuppressive chemotherapy.<br><br> 2. Hematopoietic growth factors: = 14 days after the last dose of a long-acting<br> growth factor (e.g., Pegfilgrastim) or 7 days for a short-acting growth factor.<br><br> 3. Biologic (anti-neoplastic) agent: = 7 days after the last dose of a biologic<br> agent.<br><br> 4. Cellular therapy: = 21 days must have elapsed from the last dose of any type of<br> cellular therapy (e.g., modified T cells, NK cells, dendritic cells, etc.) with<br> resolution of any associated toxicities.<br><br> 5. Interleukins, interferons, and cytokines (other than hematopoietic growth<br> factors): = 21 days must have elapsed from the last dose of interleukins,<br> interferon, or cytokines (other than hematopoietic growth factors).<br><br> 6. Antibodies: 7 days or 3 half-lives (whichever is longer) but not longer than 30<br> days, and toxicity related to prior antibody therapy must be recovered to Grade<br> = 1.<br><br> 7. Autologous Stem Cell Transplant or Rescue: = 6 weeks must have elapsed since<br> stem cell transplant or rescue.<br><br> 8. Radiotherapy (XRT): = 14 days after local palliative XRT (small port); = 3<br> months must have elapsed if prior craniospinal XRT was received, if = 50% of<br> the pelvis was irradiated, or if TBI was received; = 6 weeks must have elapsed<br> if other substantial bone marrow radiation was given.<br><br> 9. Investigational Agents Not Otherwise Specified: = 28 days must have elapsed<br> since the last dose of any investigational agent not specified above.<br><br> 10. Thoracic Surgery or Procedure: = 28 days must have elapsed since prior<br> thoracotomy, thoracoscopy, or thoracentesis.<br><br> - Adequate Bone Marrow Function Defined: Peripheral absolute neutrophil count (ANC) =<br> 750/mm3, Platelet count = 50,000/mm3. Must be transfusion independent defined as not<br> receiving platelet transfusions for at least 7 days before enrollment<br><br> - Adequate Renal Function Defined As Creatinine clearance or radioisotope = GFR<br> 70ml/min/1.73 m2<br><br> - Adequate Liver Function Defined As Total bilirubin = 1.5 x the upper limit of normal<br> (ULN) for age, ALT (SGPT) = 3 x the ULN. For this study, the ULN for ALT (SGPT) is<br> 45 U/L.<br><br> - Adequate Pancreatic Function Defined As Serum lipase = 1.5 x ULN<br><br> - Adequate Thyroid Function Defined As Normal free T4<br><br> - Adequate Pulmonary Function Defined As No dyspnea at rest, Pulse oximetry > 92% on<br> room air<br><br> - Adequate Cardiac Function Defined As QTc = 480 msec, Shortening fraction = 27% by<br> echocardiogram or ejection fraction = 50% by gated radionuclide study or<br> echocardiogram<br><br> - Urine protein: Meets one of the following criteria: (1) urinary protein by urine<br> dipstick is = 100 mg/dL or = 2+; OR (2) Urine Protein Creatinine (UPC) ratio < 3.5;<br> OR (3) if 24-hour urine protein was measured, urinary protein = 3500 mg.<br><br> - Life expectancy of at least 4 months.<br><br> - Negative urine or serum pregnancy test in women of childbearing potential.<br><br> - Sexually active patients of reproductive potential are not eligible unless they have<br> agreed to use an effective contraceptive method for the duration of their study<br> participation. Patients should maintain adequate contraception for at least 5 months<br> after the last dose of atezolizumab. Adequate contraception is defined as abstinence<br> or use of contraceptives with a failure rate of < 1% per year.<br><br> - All participants and their parents or legal guardians must sign a written informed<br> consent and assent (if applicable).<br><br>Exclusion Criteria:<br><br> - Pregnancy or Breast-Feeding<br><br> - Active metastatic disease outside of the lungs including bone, CNS, or any<br> extrapulmonary involvement<br><br> - > Grade 1 pleural effusion<br><br> - Prior lung radiation<br><br> - Active autoimmune disorder that has required systemic treatment in the past 12<br> months, or a documented history of severe autoimmune disorder, or a syndrome that<br> requires systemic steroids or immunosuppressive agents. Participants with type 1<br> diabetes mellitus, hypothyroidism only requiring hormone replacement, or skin<br> disorders such as vitiligo, psoriasis, or alopecia not requiring systemic treatment<br> may be permitted to enroll.<br><br> - Significant cardiovascular disease (such as New York Heart Association Class II or<br> greater cardiac disease, myocardial infarction, or cerebrovascular accident) within<br> 3 months before initiation of study treatment, unstable arrhythmia, or unstable<br> angina.<br><br> - Prior treatment with an immune checkpoint inhibitor is allowed provided it was not<br> permanently discontinued due to toxicity and was not given with radiation.<br><br> - Active tuberculosis<br><br> - Any medical condition or illness that would compromise the participants's ability to<br> undergo surgery, cause unacceptable safety risk, or compromise compliance with the<br> protocol.<br><br> - Chronic use of immunosuppressive therapies.<br><br> - Participants with an uncontrolled infection.<br><br> - Subjects who have received prior allogeneic stem cell transplant or solid organ<br> transplant are not eligible.<br><br> - Participants who, in the opinion of the investigator, may not be able to comply with<br> the protocol-required procedures.<br><br> - Participants who are currently receiving any other investigational or anti-cancer<br> agents.<br><br> - Participants with a known history of HIV, hepatitis B, and/or hepatitis C (testing<br> not required as part of screening).<br><br> - Current or prior pneumonitis.<br><br> - Live/attenuated vaccine administered within 30 days of enrollment
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of participants with Dose limiting toxicity at Dose Level 1;Number of participants with Dose limiting toxicity at Dose Level 2
- Secondary Outcome Measures
Name Time Method Disease Control Rate;Progression-free survival (PFS);Overall Survival