A phase 1 study of combined guadecitabine and cisplatin in platinum refractory germ cell cancer.

ABSTRACT:

Purpose

Germ cell tumors (GCTs) are cured with therapy based on cisplatin, although a clinically significant number of patients are refractory and die of progressive disease. Based on preclinical studies indicating that refractory testicular GCTs are hypersensitive to hypomethylating agents (HMAs), we conducted a phase I trial combining the next-generation HMA guadecitabine (SGI-110) with cisplatin in recurrent, cisplatin-resistant GCT patients.

Methods

Patients with metastatic GCTs were treated for five consecutive days with guadecitabine followed by cisplatin on day 8, for a 28-day cycle for up to six cycles. The primary endpoint was safety and toxicity including dose-limiting toxicity (DLT) and maximum tolerated dose (MTD).

Results

The number of patients enrolled w

SUBMITTER: Albany C 

PROVIDER: S-EPMC7826483 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature