Study Design and Patients
tumor, sarcoma, hematologic, kidney, and hepatic function, Hutchinson Cancer, Cancer
SARCOMA, TUMOR, CANCER
This open-label, phase 1 nonrandomized controlled trial of IT GLA-SE was conducted at the Seattle Cancer Center Alliance and Fred Hutchinson Cancer Research Center from November 17, 2014, to March 16, 2016, in accordance with International Conference on Harmonization Guidelines for Good Clinical Practice and the Eligible patients were 18 years or older with metastatic sarcoma and at least 1 palpable, superficial tumor safely accessible for bedside injection that would also be irradiated. Patients were required to have adequate hematologic, kidney, and hepatic function. Patient race and ethnicity information were collected by self-report. A complete list of eligibility criteria is provided in eFigure 1 in 