Patients
sarcoma, synovial sarcoma, tumor
TUMOR, DISEASE, SARCOMA, SYNOVIAL SARCOMA, LEIOMYOSARCOMA
Twelve patients (median [range] age, 65 [34-78] years; 8 [67%] female and 4 [33%] male; 9 [75%] White, 1 [8%] Asian, and 2 [17%] with no race or ethnicity reported) with metastatic sarcoma with a superficial tumor amenable to bedside IT injection concurrent with radiotherapy given over 2 weeks were enrolled in the trial. Six patients were treated in the 5-μg cohort, and after observing no dose-limiting toxic effects, 6 additional patients were treated in the 10-μg cohort. One patient was not enrolled because of screening failure.Six patients (50%) had leiomyosarcoma; the next most common subtype was synovial sarcoma (2 [17%]). The mean (SD) largest dimension of the injected tumor was 5.4 (3.6) cm. Patients had a median of 5 sites (range, 2-9 sites) of disease and 3.5 lines of treatment (range, 0-5 lines) before enrollment (