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Bever, Katherine M; Thomas, 2nd, Dwayne L; Zhang, Jiajia; Diaz Rivera, Ernie A; Rosner, Gary L; Zhu, Qingfeng; Nauroth, Julie M; Christmas, Brian; Thompson, Elizabeth D; Anders, Robert A; Judkins, Carol; Liu, Meizheng; Jaffee, Elizabeth M; Ahuja, Nita; Zheng, Lei; Azad, Nilofer S
Clinical epigenetics, 02/2021, Volume: 13, Issue: 1Journal Article
Epigenetic therapies may modulate the tumor microenvironment. We evaluated the safety and optimal sequence of combination DNA methyltransferase inhibitor guadecitabine with a granulocyte macrophage-colony-stimulating-factor (GM-CSF) secreting colon cancer (CRC) vaccine (GVAX) using a primary endpoint of change in CD45RO + T cells. 18 patients with advanced CRC enrolled, 11 underwent paired biopsies and were evaluable for the primary endpoint. No significant increase in CD45RO + cells was noted. Grade 3-4 toxicities were expected and manageable. Guadecitabine + GVAX was tolerable but demonstrated no significant immunologic activity in CRC. We report a novel trial design to efficiently evaluate investigational therapies with a primary pharmacodynamic endpoint.Trial registry Clinicaltrials.gov: NCT01966289. Registered 21 October, 2013.
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