Phase 1 Trial of Guadecitabine With Vaccine and Cyclophosphamide for Metastatic Colorectal Cancer

Title: A Pilot Study of SGI-110 in Combination With an Allogeneic Colon Cancer Cell Vaccine (GVAX) and Cyclophosphamide (CY) in Metastatic Colorectal Cancer (mCRC) as Maintenance Therapy¹

Principal Investigators: Nilofer Azad, MD, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Description: For this randomized, open-label, phase 1 trial, researchers are evaluating whether guadecitabine (SGI-110), a DNA methyltransferase inhibitor, is safe and effective in combination with cyclophosphamide and GVAX, a colon cancer tumor vaccine, among patients with metastatic colorectal cancer.

All patients will initially receive cyclophosphamide, GVAX, and guadecitabine; if a response is recorded, patients will be assigned to receive cyclophosphamide and GVAX or guadecitabine alone.

The primary outcome measures are the difference in CD45RO+ tumor infiltrating lymphocytes in biopsies taken before/after treatment and the number of adverse events. Secondary outcomes include overall and progression-free survival.

For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT01966289.

Status: This study is open and recruiting patients as of October 23, 2017.

This study is sponsored by the Sidney Kimmel Comprehensive Cancer Center.

Reference

1. Clinicaltrials.gov. SGI-110 in combination with an allogeneic colon cancer cell vaccine (GVAX) and cyclophosphamide (CY) in metastatic colorectal cancer (mCRC).  NCT01966289. https://clinicaltrials.gov/ct2/show/NCT01966289. Accessed October 23, 2017.