Albany C, et al. - Researchers undertook this open-label, phase 1 study to test the combination of guadecitabine (SGI-110; a new hypomethylating dinucleotide of decitabine and deoxyguanosine resistant to degradation by cytidine deaminase) and cisplatin with respect to safety and clinical activity among patients with platinum-refractory germ cell tumors (GCT). The patients were given subcutaneous guadecitabine, once-daily for 5 consecutive days, followed by cisplatin on day 8 with growth factor support (GFS) in a 28-day treatment cycle. They also employed a modified toxicity probability interval dose-escalation design, wherein, patients were administered guadecitabine doses of 30-45 mg/m² plus cisplatin 100 mg/m² up to 6 cycles, until progression or intolerable toxicity. The maximum tolerated dose of guadecitabine was 30 mg/m² x 5 days and cisplatin 100 mg/m². Experts reported 2/14 complete response persisting more than 6 months. The estimated objective response rate was 28.5%. In this first investigation of chemo-priming with epigenetic therapy in GCT, findings revealed the safety, tolerability as well as promising activity, with 4/14 responses, of guadecitabine 30 mg/m² x 5 days and cisplatin 100 mg/m² with GFS in this highly treatment-refractory patient population.