SGI-110 in Combination With an Allogeneic Colon Cancer Cell Vaccine (GVAX) and Cyclophosphamide (CY) in Metastatic Colorectal Cancer (mCRC)

NCT01966289 ↗

Phase 1 Completed 18 enrolled Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Astex Therapeutics, Ltd · collab Susan Cohan Colon Cancer Foundation · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This study will be looking at whether CY/GVAX in combination with SGI-110 is effective (recruits CD45RO+ T cells to the tumor which may be a marker of anti-tumor activity) and safe in patients with metastatic colon or rectum cancers.

Timeline

Start: 2014-04-14
Primary completion: 2020-06-06
Completion: 2020-06-06

Publications

Bever KM, Thomas DL 2nd, Zhang J, Diaz Rivera EA, Rosner GL, Zhu Q, Nauroth JM, Christmas B, Thompson ED, Anders RA, Judkins C, Liu M, Jaffee EM, Ahuja N, Zheng L, Azad NS. A feasibility study of combined epigenetic and vaccine therapy in advanced colorectal cancer with pharmacodynamic endpoint. Clin Epigenetics. 2021 Feb 2;13(1):25. doi: 10.1186/s13148-021-01014-8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CY	Unknown	200 mg/m2	Intravenous
Subject	GVAX	Vaccine	5e+07 cells	Intravenous
Subject	GVAX	Vaccine	5e+08 cells	Intravenous
Subject	Guadecitabine	Oligonucleotide (other)	60 mg/m2	Subcutaneous

SGI-110 in Combination With an Allogeneic Colon Cancer Cell Vaccine (GVAX) and Cyclophosphamide (CY) in Metastatic Colorectal Cancer (mCRC)

Summary

Timeline

Publications

Drugs

Indications