The median overall survival time was 25 weeks. Bronchopulmonary hemorrhage from Grade 3 thrombocytopenia ( N = 1) was a DLT. Four patients had mixed responses, and one patient had a response in a brain metastasis. One patient showed a metabolic response on FDG PET and NaF PET. NaF PET revealed more sites of metastases than did FDG PET. Patients received 1-6 cycles of 223RaCl 2 cumulative doses were 6.84-57.81 MBq. Objective measurements included changes in standardized uptake values of positron emission tomography (PET 18FDG and/or NaF-18) and single-photon emission CT/CT (99mTc-MDP) as well as alkaline phosphatase and bone turnover markers at baseline, midstudy, and the end of the study.Īmong 18 patients enrolled (including 15 males) aged 15-71 years, tumor locations included spine ( n = 12, 67%), pelvis ( n = 10, 56%), ribs ( n = 9, 50%), extremity ( n = 7, 39%), and skull ( n = 2, 11%).
Radium 223 dichloride trial#
We hypothesized that alpha-emitting, bone-targeting radium 223 dichloride ( 223RaCl 2) can be safely administered to patients with osteosarcoma and that early signals of response or resistance can be assessed by quantitative and qualitative correlative imaging studies and biomarkers.Ī 3+3 phase I, dose-escalation trial of 223RaCl 2 (50, 75, and 100 kBq/kg) was designed in patients with recurrent/metastatic osteosarcoma aged ≥15 years. The prognosis of metastatic osteosarcoma continues to be poor. 11 Department of Radiology, Baylor College of Medicine, Houston, Texas.10 Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.9 Sarcoma Oncology Center, Santa Monica, California.8 Department of Sarcoma Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.7 Children's Center for Cancer and Blood Diseases, Children's Hospital of Los Angeles, University of Southern California Keck School of Medicine, Los Angeles, California.6 Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas.5 Docrates Cancer Center, Helsinki, Finland.4 Department of Nuclear Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.3 Department of Pediatric Hematology/Oncology, Cleveland Clinic Foundation Cleveland, Ohio.
2 Division of Pediatrics, The University of Texas MD Anderson Cancer Center, Houston, Texas. 1 Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas.
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